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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
July 13, 2005
05-28
_______________________________
PRODUCT
Giant and Tops brands, Ice Cream, half gallon, packed in an oval paperboard
tub displaying Chocolate Chip Ice Cream on the tub but sealed with a mismatched
lid labeled as Butter Pecan Ice Cream. The lids display a scoop of ice cream
and a pecan nut, Recall # F-478-5
CODE
Sell by FEB 24 2006
RECALLING FIRM/MANUFACTURER
Giant Food Incorporated, Jessup, MD, by telephone and e-mail on May 20, 2005,
and by press release on June 7, 2005. Firm initiated recall is ongoing.
REASON
Butter Pecan Ice Cream is in a 2-pc container: lower "cup" identifies the
product as Chocolate Chip and lists the ingredient statement for Chocolate
Chip, which does not contain pecans. The upper "lid" identifies the product
as Butter Pecan. Hazard posed to pecan-sensitive consumers who may consume
the Butter Pecan believing it was actually Choc Chip, which does not contain
pecans.
VOLUME OF PRODUCT IN COMMERCE
2,910 (half gallon) units
DISTRIBUTION
NY, PA, OH, MD, WV and VA
______________________________
PRODUCT
Recaito "El Huerto" Crudo Al Natural, Recall # F-433-5
CODE
UPC Codes: Recaito 24/14 oz/No: 8951044690; Recaito 12/28 oz/No: 8951044691;
Recaito 6/56 oz/No: 8951044719; Recaito 1/35 lbs/No: 8951044745; Sofrito
24/12 oz./No: 8951044486; Sofrito 12/32 oz/No: 8951044863.
RECALLING FIRM/MANUFACTURER
Procesadora y Empacadora Del Caribe, Inc, Ponce, PR, by visit beginning on
March 22, 2005. Firm initiated recall is ongoing.
REASON
Some ingredients used in the formula for Recaito and Sofrito, were not declared
on the finished product, and the missing ingredients included colors - FD&C
Blue No. 1 and FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
1096 boxes
DISTRIBUTION
Puerto Rico - local supermarkets such as Pueblos, Pitusa, Econo, Mr. Special,
Selectos, and Super Max
______________________________
PRODUCT
Popsicle Brand Smart Set, packaged to contain three items: 1) one .06 oz.
tube of Scribblers, Firecracker, or Wild Bunch lipstick; 2) one .35 oz tube
of Pop Ups lip balm; and 3) one .15 oz tube of Fantastic Fruity lip gloss.
Smart Sets were packed, shpped and delivered in a corrugated display tray,
each containing four Popsicle Brand Smart Sets. Recall # F-435-5
CODE
All product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wal Mart Stores, Inc., Bentonville, AK, by email beginning
on April 8, 2005.
Manufacturer: Yiwu Siya Cosmetics, Yiwu, Zhejiang, China. Firm initiated
recall is complete.
REASON
Wild Bunch Lipstick contains non-permitted color additive, Lake Red C (formerly
certifiable as D&C Red No 8).
VOLUME OF PRODUCT IN COMMERCE
34,000 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Recaito El Pilon 24/12, Recall # F-442-5;
b) Recaito-Listo 24/12, Recall # F-443-5;
c) Garlic Spread El Pilon, Recall # F-444-5
CODE
a) Lot # 1033;
b) Lot # 1034;
c) Lot # 1032
RECALLING FIRM/MANUFACTURER
Rico Chef Food Products, Inc, Morovis, PR, by visit beginning on March 22,
2005. Firm initiated recall is ongoing.
REASON
Product contains undeclared color additives - FD&C Yellow #5 and Blue
#1 (which are part of a Medium Green Color added to the recaito).
VOLUME OF PRODUCT IN COMMERCE
819.5 cases
DISTRIBUTION
PR
______________________________
PRODUCT
Trader Joeís Sun Dried Tomato & Pesto Torta, 7.5 oz., Recall # F-448-5
CODE
USE BY 5/29/05
RECALLING FIRM/MANUFACTURER
Trader Joeís Company, Monrovia, CA, by press release and email on May 5,
2005. Firm initiated recall is ongoing.
REASON
The product does not bear ingredient statements.
VOLUME OF PRODUCT IN COMMERCE
272 units
DISTRIBUTION
CA, WA, OR, NV, AZ, and NM
______________________________
PRODUCT
Kercherís October Gold brand Sweet 100% Apple Cider, pasteurized, unfiltered
in 64 fl. oz. and 128fl. oz. containers, Recall # F-477-5
CODE
Lots bearing sell by dates of 3/26/2005 and 4/23/2005
RECALLING FIRM
Sunrise Orchards Inc, Goshen, IN, by telephone beginning on March 12, 2005,
by fax on March 16, 2005 and/or by letter on/or about March 17, 2005. Firm
initiated recall is complete.
REASON
FDA analysis found elevated patulin levels in these lots.
VOLUME OF PRODUCT IN COMMERCE
1,632 gallons
DISTRIBUTION
IL and IN
______________________________
PRODUCT
Melissa's Dried Shiitake Mushrooms, in 1 oz plastic bags, Recall # F-434-5
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: World Variety Produce Inc, Vernon, CA, by email and the firmís
website beginning on February 25, 2005.
Manufacturer: Clover Specialties Inc, Torrance, CA. Firm initiated recall
is complete.
REASON
The product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
684 packages (12 packages per case)
DISTRIBUTION
AK, CA, CO, CT, KY, IL, MA, ND, NV, and UT
______________________________
PRODUCT
Potato Scramble Breakfast: Scrambled Eggs, Breakfast Potatoes, Corn Bread,
Cherry Sauce. Ready to eat meal, Recall # F-439-5
CODE
Code Date 04196 produced on July 14, 2004
RECALLING FIRM/MANUFACTURER
G.A. Food Service, Inc, St Petersburg, FL, by telephone and letter beginning
on April 1, 2005. Firm initiated recall is ongoing.
REASON
A human finger tip was found in a pre-packaged Potato Scramble Breakfast
meal.
VOLUME OF PRODUCT IN COMMERCE
3,620 Individual Meals
DISTRIBUTION
CA
______________________________
PRODUCT
Bakerís Inn Sliced Bakery Bread StoneGround Whole Wheat with Extra Fiber,
packaged in 28-oz. loaves. Recall # F-476-5
CODE
All codes
RECALLING FIRM/MANUFACTURER
Interstate Brands Corp Headquarters, Kansas City, MO, by e-mail on June 3,
2005. Firm initiated recall is complete.
REASON
The bread was contaminated with mold prior to its "use by" date.
VOLUME OF PRODUCT IN COMMERCE
Approximately 572,835 loaves
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Bethanechol Chloride Tablets, USP 5mg. NDC 53265-339-10,
(100s), Recall # D-284-5;
b) Bethanechol Chloride Tablets, USP, 10mg. NDC 53265-340-
10, (100s), Recall # D-285-5;
c) Bethanechol Chloride Tablets, USP, 25mg. NDC 53265-338-
10, (100s), Recall # D-286-5;
d) Bethanechol Chloride Tablets, USP, 50mg. NDC 53265-341-
10, (100s), Recall # D-287-5
CODE
All Lots bring recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
13 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Butalbital, Acetaminophen and Caffeine Tablets, USP,
50mg/325mg/40mg, NDC 53265-236-10 and NDC 53265-236-50,
(100s and 500s), Recall # D-288-5;
b) Butalbital, Acetaminophen and Caffeine Tablets, USP,
50mg/500mg/40mg, NDC 53265-235-10 and NDC 53265-235-50,
(100s and 500s), Recall # D-289-5
CODE
All lots are bring recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
181 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Indomethacin Capsules, USP, 25 mg, NDC 53265-267-10 and
NDC 53265-267-11 (100s and 1000s), Green,
Recall # D-290-5;
b) Indomethacin Capsules, USP, 50 mg, NDC 53265-268-10 and
NDC 53265-268-50, (100s and 500s), Green,
Recall # D-291-5;
c) Indomethacin Extended-Release Capsules, USP 75 mg, NDC
53265-269-60 and NDC 53265-269-10 (60s and 100s),
Yellow/Clear, Recall # D-292-5
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
38 lots
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Naproxen Sodium Tablets, USP, 275mg. NDC 53265-363-10
and NDC 53265-363-50 (100s and 500s). Recall # D-293-5;
b) Naproxen Sodium Tablets, USP. 550mg. NDC 53265-364-10
and NDC 53265-364-50. (100s and 500s). Recall # D-294-5
CODE
All codes are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
20 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Methamphetamine Hydrochloride Tablets, USP CII, 5 mg, NDC 53265-396-10 (100s),
Recall # D-295-5
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
6 lots
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Methocarbamol Tablets, USP, 500mg, NDC 53265-265-10 and
NDC 53265-265-50 (100s and 500s), Recall # D-296-5;
b) Methocarbamol Tablets, USP, 750mg, NDC 53265-264-10 and
NDC 53265-264-50 (100s and 500s), Recall # D-297-5
CODE
All codes are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
19 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Lithium Carbonate Capsules, USP, 150mg. NDC 53265-355-
10 and NDC 53265-355-50. (100s and 500s),
Recall # D-298-5;
b) Lithium Carbonate Capsules, USP, 600mg. NDC 53265-355-
10 (100s), Recall # D-299-5;
c) Lithium Carbonate Capsules, USP, 300mg. NDC 53265-270-
10 and NDC 53265-270-11. (100s and 1000s), Pink.
Recall # D-300-5;
d) Lithium Carbonate Extended-Release Tablets, USP, 300mg.
NDC 53265-283-10. (100s), Recall # D-301-5
CODE
All codes are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
505 lots
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Diphenoxylate Hyrdochloride and Atropine Sulfate Tablets, USP 2.5mg/0.025mg,
CV, NDC 53265-237-10, NDC 53265-237-50, and NDC 53265-237-11. (100s, 500s,
1000s), Recall # D-302-5
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
38 lots
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
5 mg/500 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
packs, NDC #51079-420-20: 10 sheets of 10 unit dose
tablets, NDC #51079-420-21: 5 sheets of 20 unit dose
tablets, NDC #51079-420-99: 15 sheets of 6 unit dose
tablets, Recall # D-303-5;
b) Lithium Carbonate Capsules, USP, 300 mg; an Rx oral
antimanic medication; single capsule unit dose blister
packs, 10 sheets of 10 unit dose capsules per carton;
NDC #51079-269-20, Recall # D-304-5;
c) Promethazine Hydrochloride Tablets, USP, 25 mg; an oral
antihistamine/sedative/antiemetic; single tablet unit
dose blister packs, 10 sheets of 10 unit dose tablets
per carton; NDC # 51079-895-20, Recall # D-305-5;
d) Lithium Carbonate Extended-Release Tablets, USP, 300 mg;
an Rx oral antimanic medication; single tablet unit dose
blister packs, 10 sheets of 10 unit dose tablets per
carton; NDC #51079-253-20, Recall # D-306-5;
e) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/ 500 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC #51079-867-21, Recall # D-307-5;
f) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/750 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC # 51079-748-21, Recall # D-308-5;
g) Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5
mg/325 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC # 51079-274-21, Recall # D309-5;
h) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/325 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC # 51079-295-21, Recall # D-310-5;
i) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
10 mg/325 mg, C-III; an Rx oral schedule C-III narcotic analgesic and antitussive;
single tablet unit dose blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC # 51079-305-21, Recall # D-311-5
CODE
a) NDC # 51079-420-20: lots 4C904, 4D247, 4D265, 4F055,
4H100, 4J390, 4J450, 4M601, 4M643, 4P837, 4V011, 4V077,
5B231, 5B304, 5C449. NDC #51079-420-21: lots 4D319,
4F044, 4J381, 4K531, 4S859, 4S958, 5A116, 5B306. NDC#
51079-420-99: lots 4D321, 4J340, 4J375, 4J441, 4K538,
4M669, 4P762, 4S869, 4V063, 4V984, 5B220, 5C339, 5F533;
b) Lot 4S867;
c) Lot 5C500;
d) Lots 4M695, 4V059, 4V996;
e) Lots 4D258, 4K516, 4P804, 4H111, 4V024, 5C390;
f) Lots 4H091, 4M650, 4V990, 5C474;
g) Lot 4V037;
h) Lot 4V978;
i) Lot 4V040
RECALLING FIRM/MANUFACTURER
Recalling Firm: UDL Laboratories, Inc., Rockford, IL, by letters on May 27,
2005.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
The drug products repackaged by UDL were recalled by the manufacturer, Able
Laboratories due to a lack of assurance that testing conducted for release
and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
284,703 cartons of 100 u/d and 21,186 cartons of 90 u/d
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Hydroxyzine Hyrdochloride Tablets, USP 10mg, NDC 53265-
387-10, NDC 53265-387-50, and NDC 53265-387-11. (100s,
500s, 1000s), Recall # D-312-5;
b) Hydroxyzine Hyrdochloride Tablets, USP 25mg, NDC 53265-
388-10, NDC 53265-388-50, and NDC 53265-388-11. (100s,
500s, 1000s), Recall # D-313-5;
c) Hydroxyzine Hyrdochloride Tablets, USP 50mg, NDC 53265-
389-10, NDC 53265-389-50, and NDC 53265-389-11. (100s,
500s, 1000s), Recall # D-314-5;
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
23 lots
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Salsalate Tablets, USP 500mg, NDC 53265-132-10 and
NDC 53265-132-50, (100s and 500s), Recall # D-315-5;
b) Salsalate Tablets, USP 750mg, NDC 53265-133-10 and
NDC 53265-133-50, (100s and 500s), Recall # D-316-5
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
48 lots
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Carisoprodol Tablets, USP 350mg, NDC 53265-266-10, NDC 53265-266-50 and NDC
53265-266-11, (100s and 500s, 1000s), Recall # D-317-5
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
335 lots
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Propoxyphene Napsylate and Acetaminophen Tablets, USP,
100mg/650mg (Pink) CIV. NDC 53265-256-10, NDC 53265-256-
50 and NDC 53265-256-11. (100s, 500s and 1000s)).
Recall # D-318-5;
b) Propoxyphene Napsylate and Acetaminophen Tablets, USP,
100mg/650mg (White) CIV. NDC 53265-261-10, NDC 53265-
261-11 and NDC 53265-261-50. (100s, 500s and 1000s),
Recall # D-319-5
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
526 lots
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Phentermine HCl Capsules, USP, 15 mg, CIV,
NDC 53265-346-10 and NDC 53265-346-11 (100s and 1000s),
Grey/Yellow, Recall # D-320-5;
b) Phentermine HCl Tablets, USP, 37.5 mg, CIV, NDC 53265-
257-10 and NDC 53265-257-11. (100s and 1000s),
Recall # D-321-5;
c) Phentermine HCl Capsules, USP, 30 mg CIV, NDC 53265-258-
10 and NDC 53265-258-11 (100s and 1000s). Yellow/Yellow,
Recall # D-322-5;
d) Phentermine HCl Capsules, USP, 30 mg BEADS, NDC 53265-
259-10 and NDC 53265-259-11, (100s and 1000s),
blue/clear, CIV, Recall # D-323-5
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and
letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated
recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
208 lots
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Ciprofloxacin Tablets, USP, 250 mg. 100-tablet bottles,
NDC 52555-769-01 Recall # D-324-5;
b) Ciprofloxacin Tablets, USP, 500 mg., 100-tablet bottles,
NDC 52555-770-01, Recall # D-325-5;
c) Ciprofloxacin Tablets, USP, 750 mg., 50-tablet bottles,
NDC 52555-771-50. Recall # D-326-5
CODE
a) Lot number B040015, Exp. April, 2006;
b) Lot numbers B040017 Exp. April 2006, B040018 Exp. April
2006, B040019 Exp. April 2006, B040020 Exp. April 2006,
B040021 Exp. April 2006, B040075 Exp. August 2006,
B040081 Exp. August 2006, B040082 Exp. August 2006, and
B040120 Exp. October 2006, B050012 Exp. January 2007,
and B050022 Exp. January 2007;
c) Lot number B040016, Exp. April 2006
RECALLING FIRM/MANUFACTURER
Martec Scientific, Inc., Kansas City, MO, by telephone and letters on May
11, 2005. Firm initiated recall is ongoing.
REASON
Method validation deviations for finished product testing and inadequate
Out of Specification (OOS) investigations for Blend Uniformity testing.
VOLUME OF PRODUCT IN COMMERCE
8,289/100/250-mg. tablet bottles; 45,996/100/500-mg. tablet bottles; and
6,290/50/750-mg. tablet bottles.
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Vinorelbine Tartrate Injection, 10mg/mL, 1 and 5 mL vials, For Intravenous
Use Only, Rx only, NDC 10019-970-02 ---- Also under other brand as Vinorelbine
Tartrate Injection, 10mg/mL, ESI Lederle, Philadelphia, PA, Recall # D-264-5
CODE
1mL lots: 601248 exp 7/05; 601416 exp 11/05; A71275 exp 6/06; A93267 exp
8/06. 5mL lots: 601216 exp 7/05; 601217 exp 7/05; 601218 exp 7/05; 601219
exp 7/05; 601412 exp 8/05; A71276 exp 3/06; A71277 exp 3/06; A71278 exp 4/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Anesthesia and Critical Care, New Providence,
NJ, by letter on May 23, 2005.
Manufacturer: Wyeth Parenterals Divison of Wyeth Holdings Corp. Carolina,
PR. Firm initiated recall is ongoing.
REASON
Exceeds Impurity Level
VOLUME OF PRODUCT IN COMMERCE
1 mL = 54202 vials; 5 mL = 33055 vials
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-1417-5;
b) Recovered Plasma, Recall # B-1418-5
CODE
a) and b) Unit number: 4649058
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, Oklahoma, by facsimile on September
26 and October 2, 2003, and by letter dated October 28, 2003. Firm initiated
recall is complete.
REASON
Blood products, which were collected from a donor who was at increased risk
for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1457-5;
b) Platelets, Leukocytes Reduced, Recall # B-1458-5
CODE
a) and b) Unit number 13GE12726
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI,
by telephone on April 7, 2004, and by letters on April 8, 2004, and May 11,
2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus
(anti-HCV), but were collected from an ineligible donor based on the disclosure
of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1459-5
CODE
Unit number 13GX80914
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI,
by telephone on September 16, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated
with Streptococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B- 1460-5
CODE
Unit numbers: 13GS09185, 13GS09209, 13GT01072, 13GT01073, and 13GW40213
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI,
by telephone on July 27, 2004. Firm initiated recall is complete.
REASON
Blood products, corresponding to units of Platelets that were pooled and
possibly contaminated with Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MI
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1461-5
CODE
Unit number 13FE27548
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI,
by telephone on April 23, 2004, and by letter on May 12, 2004. Firm initiated
recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated
with Micrococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1463-5;
b) Platelets Pheresis, Leukocytes Reduced
Irradiated, Recall # B-1464-5
CODE
a) Unit numbers: 04GP55472P1, 04GP55472P2, 04GP55512,
04GP55558P1, 04GP55558P2, 04GP55632P1, 04GP55632P2,
04GP55764P1, 04GP55764P2, 04GP55848P1, 04GP55848P2,
04GP55963P1, 04GP55963P2, 04GP56225P1, 04GP56225P2,
04GP56373P1, 04GP56373P2, 04GP56724P1, 04GP56724P2,
04GP56938P1, 04GP56938P2, 04GP57444P1, 04GP57444P2,
04GP57602P1, 04GP57602P2, 04GP57886P1, 04GP57886P2,
04GP58672P1, 04GP58672P2, 04GP58804P1, and 04GP58804P2;
b) Unit numbers: 04GP55708, 04GP56093P1, 04GP56093P2,
and 04GP58860
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by facsimile
and letter on March 25, 2005. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
MA, ME, NH, and PA
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1478-5;
b) Recovered Plasma, Recall # B-1479-5
CODE
a) and b) Unit number: KE04874
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by electronic mail on September 24,
2002 or by letter dated November 7, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose arm inspection was
unsatisfactory, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Austria
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1481-5;
b) Recovered Plasma, Recall # B-1482-5
CODE
a) Unit number: 13GS09835;
b) Unit numbers: 13GS09835, 13GX62208
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by
telephone and e-mail on February 8, 2005 and by letter dated February 15,
2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for viral markers, but were collected
from a donor who was subsequently determined to have multiple risk factors
for increased incidence of infection with the human immunodeficiency virus
(HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA, MI, and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1483-5
CODE
Unit number: 13GW39888
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by
telephone on September 21, 2004 and by letter dated September 23, 2004. Firm
initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
_______________________________
PRODUCT
Red Blood Cells (Apheresis), Recall # B-1500-5
CODE
Unit FL64225
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on January 29, 2004. Firm
initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells (Apheresis), Recall # B-1502-5
CODE
Unit number: F97462
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on May 24, 2004. Firm initiated
recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________
PRODUCT
Red Blood Cells, Recall # B-1462-5
CODE
Unit numbers: 1635979, 1635982, 1635981, 1635986, 1635983, 1635990, 1635987,
and 1635989
RECALLING FIRM/MANUFACTURER
Department of the Army, Armed Services Blood Bank Center, Madigan Army
Medical Center, Tacoma, WA, by facsimile on October 8, 2002. Firm initiated
recall is complete.
REASON
Blood products, incorrectly tested for human immunodeficiency virus (HIV)
and hepatitis C virus (HCV) by the nucleic acid testing (NAT) method, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
WA
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1465-5
CODE
Unit number: 13FE26453
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI,
by telephone on October 24, 2003 and by letter dated November 18, 2003.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1466-5
CODE
Unit 13GV56308
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by
telephone on September 15, 2004 and by letter dated September 22, 2004. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
_______________________________
PRODUCT
Red Blood Cells, Recall # B-1498-5
CODE
Unit F89838
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on September 23, 2002.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose body temperature was
not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1499-5
CODE
Unit LP06569
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on October 9, 2002. Firm
initiated recall is complete.
REASON
Blood product, which was not manufactured within the acceptable time frame
after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1501-5
CODE
Unit number KE21318
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on July 19, 2004. Firm
initiated recall is complete.
REASON
Blood product, which was collected from a donor who was diagnosed with herpes,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1505-5
CODE
Unit number: LW28169
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on September 8, 2003. Firm
initiated recall is complete.
REASON
Blood product, which was collected from a donor whose hemoglobin was not
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1506-5
CODE
Unit number: FC45433
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by letter dated September 9, 2003. Firm
initiated recall is complete.
REASON
Blood product, which was collected from a donor with an unacceptable body
temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1507-5
CODE
Unit Numbers: GJ07251, GJ07252, GJ07253 (double unit), GJ07254 (double unit),
GJ07255, GJ07355 (double unit), GJ07359 (triple unit), GJ07393 (double unit),
GJ07397 (double unit), and GJ07401 (double unit)
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by letter dated July 23, 2003. Firm
initiated recall is complete.
REASON
Blood products, which were shipped at unacceptable storage temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
CA
______________________________
PRODUCT
a) Vaxcel Plastic Low Profile Port (non-valved) chest port,
with 6Fr Polyurethane Catheter, Catalog 45-333, Material
#M001453330. Recall # Z-0944-05;
b) Vaxcel Plastic Low Profile (non-valved) chest port, with
8Fr Silicone Catheter, Catalog #45-336, Material
#M001453360. Recall # Z-0945-05;
c) Vaxcel Plastic Low Profile (non-valved) chest port, with
8Fr Polyurethane Catheter, Catalog # 45-338, Material
#M001453380. Recall # Z-0946-05
CODE
a) 914663, 914663D, 924196, 927904, 973169, 994958,
1000904, 1000905, 1003264, 1017119, 1018949, 1023552,
1033976, 1037228, 1037879;
b) 791550, 915867, 1010168, 1017745, 1022134, 1022488,
1024234, 1038298, 791550D;
c) 791549, 915868, 919482, 922594, 923705, 1000906,
1001279, 1003265, 1022911, 1034615, 922594D, 923705D
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on
June 8, 2005.
Manufacturer: Boston Scientific Corporation, Glens Falls, NY. Firm initiated
recall is ongoing.
REASON
Potential for port housing separation after implantation.
VOLUME OF PRODUCT IN COMMERCE
970 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Hill-Rom Century+ Bed, Model P1400. Recall # Z-0948-05
CODE
Beds built between March 2005 and May 2005.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN by letter dated May 20, 2005. Firm initiated
recall is ongoing.
REASON
Sleep bed pivot bolts may break, allowing the head section to shift or
to drop to one side.
VOLUME OF PRODUCT IN COMMERCE
218 beds
DISTRIBUTION
Nationwide, Brazil and Canada.
_______________________________
PRODUCT
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R,
Recall # Z-0947-05
CODE
All serial numbers with software version 4.0 or below
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div, McGaw Park, IL, no official
recall notification was made. Meridian software version 4.12 was released
on 10/3/03 and was implemented as a reliability improvement initiative to
all Meridian customers. Shipment of 4.12 software was completed in November
2003.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall
is complete
REASON
The saline bags may inappropriately empty/fill during the recirculation mode
of the hemodialysis system.
VOLUME OF PRODUCT IN COMMERCE
2986 units
DISTRIBUTION
Nationwide, Korea, Mexico, Guatemala, China and Hong Kong
_______________________________
PRODUCT
Co-op 16% Complete Layer Pellet, 50 pound bags, Recall # V-087-5
CODE
Lot numbers 41455114 and 41465114
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tennessee Farmers Cooperative, Rockford, TN, by telephone
on 05/31/2005.
Manufacturer: Tennessee Farmers Cooperative, La Vergene, TN. Firm initiated
recall is ongoing.
REASON
The product was co-mingled with another product which contained Amprolium
which was not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
42,000 pounds
DISTRIBUTION
TN, SC and NC
_______________________________
PRODUCT
Fort Dodge Vetisulid (sulfachlorpyridazine) Boluses, containing 2 grams sulfachlorpyridazine
per bolus, packaged in 50- and 100-count bottles, 12 bottles per case, NADA
33-127. Recall # V-089-5
CODE
Lot 1275103, Exp. Oct 05 (50 count); Lot 1275104, Exp. Nov 05 (100 count);
Lot 1275105, Exp. Nov 05 (50 count); Lot 1275106, Exp. Dec 05 (100 count);
Lot 1275107, Exp. Jan 06 (50 count); Lot 1275108, Exp. Jan 06 (100 count);
and Lot 1275109, Exp. Jan 06 (100 count).
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc, Fort Dodge, IA, by letter dated April 26, 2005.
Firm initiated recall is ongoing.
REASON
Dissolution failure at the 48-month stability test point
VOLUME OF PRODUCT IN COMMERCE
6,170/50-count bottles and 5,153/100-count bottles
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR July 13, 2005
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