FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
11/16/1994
Recalls and Field Corrections: Foods -- Class II -- 11/16/1994
November 16, 1994 94-46
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Dried Preserved Prunes, in 2.5 ounce jars. Recall #F-091-5.
CODE None.
MANUFACTURER Mei Yuan Preserved Foods Company, Ltd., China.
RECALLED BY Great Rich Trading Company, Inc., Brooklyn, New York, by
telephone on or about March 7, 1994. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY Firm estimates none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5, FD&C Yellow
No. 6, and Ponceau 4R.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Hawthorne Berry, cut, dried for use as a tea, in 8 ounce
plastic bags. Recall #F-092-5.
CODE Lot #08469 packaged 8/11/94.
MANUFACTURER Indiana Botanic Gardens, Hobart, Indiana.
RECALLED BY Manufacturer, by letter October 5, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 200 units.
REASON Product contains insect contamination.
_______________
PRODUCT Suncorn Enriched Corn Meal packaged in 2 pound bags.
Recall #F-093-5.
CODE None.
MANUFACTURER Intermares Foods, Inc., Catano, Puerto Rico.
RECALLED BY Manufacturer, by visit beginning on or about July 28, 1994.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 252 bags were distributed; firm estimates none remains on
the market.
REASON Product is mislabeled. The ingredients listed on the label
were not added to the product.
_______________
PRODUCT Tofutti brand Vanilla Almond Bark Frozen Desserts, in 3
gallon containers. Recall #F-094-5.
CODE All codes manufactured in the past 6 months.
MANUFACTURER Kemp's Foods, Inc., Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by letters of September 2 and 9, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Delaware, New York, Maryland,
Virginia, Connecticut.
QUANTITY Firm estimates very little if any product remains on the
market.
REASON Product contains undeclared almonds.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Slo-Bid Gyrocaps (Theophylline) 50 mg, extended release
capsules used in treatment of asthma. Recall #D-024-5.
CODE Lot #CN93251 EXP 7/95.
MANUFACTURER Rhone Poulenc Rorer, Fort Washington, Pennsylvania.
RECALLED BY Rhone Poulenc Rorer, Collegeville, Pennsylvania, by letter
dated October 20, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates less than 145 units remain on the market.
REASON Product does not meet dissolution specifications.
_______________
UPDATE Dexamethasone Sodium, in 5 ml bottles, Recall #D-009-5 which
appeared in the October 19, 1994, Enforcement Report is
being amended to correct the list of private labels.
Product was distributed under the following labels: Akorn,
Bausch & Lomb, Butler, Equipharm, Goldline, Infinity, Major,
Ocusoft, Phoenix, Pro-Vet, Rugby, Qualitest, Vedco, Webster,
Richmond and Pharmascience.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Lozol Tablets, (Indapamide), 1.25 mg, packaged in bottles of
100, an oral anti-hypertensive. Recall #D-023-5.
CODE Lot #MN0885 EXP 4/96.
MANUFACTURER Rhone Poulenc Rorer, Manati, Puerto Rico.
RECALLED BY Rhone Poulenc Rorer, Collegeville, Pennsylvania, by letter
June 30, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 4,563 bottles were distributed.
REASON Product is slightly below specification for dissolution.
_______________
PRODUCT Slo-Bid Gyrocaps (Theophylline) 50 mg, extended release
capsules used in treatment of asthma, in unit dose packs of
10 capsules per card and 10 cards per carton.
Recall #D-025-5.
CODE Lot #CN93755 EXP 5/95.
MANUFACTURER Rhone Poulenc Rorer, Fort Washington, Pennsylvania.
RECALLED BY Rhone Poulenc Rorer, Collegeville, Pennsylvania, by letter
September 22, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates 210 cartons of 10 x 10 blister packs remain
on the market.
REASON A 75 mg Slo-Bid Gyrocap was found in a unit dose blister
cavity.
_______________
PRODUCT Dupont Merck brand Naltrexone HCl Tablets, 50 mg, Rx, in
amber glass bottles of 14 and 50, Rx, indicated to provide
blockage of pharmacologic effect of exogenously administered
opioids. Recall #D-026-5.
CODE Lot numbers: EE156A EXP 7/97, EE156B EXP 7/97, EF172A EXP
7/97.
MANUFACTURER DuPont Merck Pharmaceutical Company, Garden City, New York.
RECALLED BY Manufacturer, by telephone October 7, 1994, followed by
letter October 12, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Germany, France, Spain, Switzerland, Portugal, Austria.
QUANTITY 28,00 tablets of lot EE156A, 17,600 tablets of lot EE156B,
and 52,318 tablets of lot EF172A were distributed.
REASON Product does not meet total degradation specifications.
_______________
PRODUCT Sinclair Pharmacal brand Boroleum Ointment, OTC, used to
relieve nasal discomfort due to head colds, hayfever, sinus
and minor nasal and skin irritations, packaged in 0.6 ounce
tubes. Recall #D-027-5.
CODE Lot numbers: S284 and 0054.
MANUFACTURER Sinclair Pharmacal Company, Inc., Fishers Island, New York.
RECALLED BY Manufacturer, by telephone October 7, 1994, followed by fax.
Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Florida, Virginia, Illinois.
-3- QUANTITY 4,824 tubes were distributed.
REASON Presence of small amounts of water in the tubes.
_______________
PRODUCT Naproxyn (naproxen) Suspension, 16 ounce bottles, a
nonsteroidal anti-inflammatory. Recall #D-028-5.
CODE Lot numbers: 40217 EXP 4/97, 40220 EXP 4/97, 40221 EXP
4/97.
MANUFACTURER Syntex, Inc., Ontario, Canada.
RECALLED BY Syntex Puerto Rico, Inc., Humacao, Puerto Rico, by letter
October 17, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,858 bottles were distributed.
REASON Some units were superpotent.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
======================
_______________
PRODUCT Red Blood Cells. Recall #B-024-5.
CODE Unit 18Z65722.
MANUFACTURER The American National Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by telephone August 5, 1994. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product contaminated with coagulase negative
Streptococcus agalactiae Group B was distributed for
transfusion.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Summit Sample Handling System; (b) Elisa Computer
Software, Version 5.2; (c) Midas Computer Software, Version
1.2; (d) Adams Computer Software, Version 1.5, 1.6, and 1.8.
Recall #B-008/011-5.
CODE (a) All serial numbers; (b) Software version 5.2; (c)
Software version 1.2; (d) Software version 1.5, 1.6, 1.8.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, (a) by letter in August 1992; (b) by letters
of June 1, 1992 and July 2, 1992; (c) telephone February
1993; (d) by letter November 8, 1993. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 200 units; (b) 137 packages; (c) 161 packages;
(d) 355 packages.
REASON Computer software with design defects that could cause the
inadvertent distribution of untested blood and blood
products was distributed.
-4- _______________
PRODUCT Red Blood Cells. Recall #B-012-5.
CODE Unit numbers: 15G70212, 15KG11359, 15KG06468, 15KG16129,
15KG20309, 15KG19594.
MANUFACTURER American National Red Cross (The), Boise, Idaho.
RECALLED BY Manufacturer, by letter October 29, 1993, November 10, 1993,
and December 2, 1993. Firm-initiated recall complete.
DISTRIBUTION Michigan, Montana, Arkansas, Florida.
QUANTITY 6 units.
REASON Blood products, collected from donors who had visited areas
designated as endemic for malaria, were distributed.
_______________
PRODUCT Red Blood Cells. Recall B-025-5.
CODE Unit #18Z65719.
MANUFACTURER The American National Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by telephone August 5, 1994. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, corresponding to Platelets, Pooled
contaminated with coagulase negative Streptococcus
agalactiae Group B, was distributed for transfusion.
_______________
PRODUCT Red Blood Cells. Recall #B-035-5.
CODE Unit #9401569.
MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on March 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product contaminated with coagulase negative
Staphylococcus epidermidis was distributed.
_______________
PRODUCT Blood grouping reagents:
(a) Anti-A, Anti-B, Anti-D (Anti-RH1), (Monoclonal),
Control, Reverse Diluent Ortho BioVue System, Product Code
707100; (b) Anti-A, Anti-B, Anti-AB, Anti-D, Anti-CDE,
(Monoclonal), Control, Ortho BioVue System, Product Code
707190; (c) Anti-C, Anti-D, Anti-E, Anti-e, (Monoclonal),
Control, Ortho BioVue System, Product Code 707200; (d) Anti-
C, Anti-E, Anti-c, Anti-e, Anti-K, (Monoclonal), Control,
Ortho BioVue System, Product Code 707280.
Recall #B-037/040-5.
CODE Lot numbers: ABE601A, ABE601B, ABE601C, ABE601D, ABE602A,
ABE603A, ABE603B, ABE603C1, ABE603D1, ABE603E1,
ABE603F2, ABE603G2, ABE603H2, ABE603I2, ABE604A,
ABE604B, ABE604C, ABE604D, ABE604E, ABE604F,
ABE605A, ABE605B, ABE605C, ABE606A, ABR301A,
-5- ABR302A, DEV700A, DEV700B, DEV700C, RHP701A,
RHP701B, RHP701C, RHP702A, RHP702B, RHP702C,
RHP702D, RHP702E, RHP703A, RHP704A, RHP704B,
RHP705A, RHP705B, RHP705C, RHP705D.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter May 4, 1994. Firm-initiated recall
complete.
DISTRIBUTION International.
QUANTITY Firm estimates that all of the product has been destroyed or
replaced.
REASON Blood grouping reagents with mislabeled cassettes were
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF; (c) Recovered
Plasma. Recall #B-016/018-5.
CODE Unit numbers: (a) 16J71558, 16J85871, 16J88934, 16F36127,
16J24182; (b) 16J71558, 16J85871, 16J88934, 16F36127; (c)
16J71558 16J85871, 16J88934, 16F36127, 16J24182.
MANUFACTURER American National Red Cross (The), Columbus, Ohio.
RECALLED BY Manufacturer, by letter July 26, 1993. Firm-initiated
recall complete.
DISTRIBUTION Ohio, California, Switzerland.
QUANTITY (a) 5 units; (b) 4 units; (c) 5 units.
REASON Blood products, which were collected from a donor who had
previously tested repeatedly reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), were
distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-026-5.
CODE Unit numbers: 18Z65719, 18Z65722, 18Z65723, 18Z65727,
18Z65736, 18Z65746.
MANUFACTURER The American National Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by telephone August 5, 1994. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 6 units.
REASON Blood products, corresponding to Platelets, Pooled
contaminated with coagulase negative Streptococcus
agalactiae Group B, were distributed for further
manufacture.
_______________
PRODUCT Recovered Plasma. Recall #B-036-5.
CODE Unit #9401569.
MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by letter June 24, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida.
-6- QUANTITY 1 unit.
REASON Blood product contaminated with coagulase negative
Staphylococcus epidermidis was distributed for further
manufacture.
_______________
PRODUCT Platelets. Recall #B-045-5.
CODE Unit numbers: Unit numbers: 16FN08909, 16FN08911,
16GL07852, 16GL07857, 16GL07858, 16GL07863, 16GL07865,
16GL07866, 16GL07867, 16GL07868, 16GL07869, 16GL07871,
16GL07878, 16GL07884, 16GL07885, 16GL07890, 16GL07891,
16GL07894, 16GL07895, 16GL07896, 16GL07898, 16GL07899,
16GL07901, 16GL07902, 16GL07904, 16GL07907, 16GL07908,
16GL07911, 16GL07912, 16GL07913, 16GL07914, 16GL07915,
16GL07916, 16GL07917, 16GL01919, 16GL07921, 16M74952,
16M74953, 16M74954.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, by letter March 16 and 17, 1993. Firm-
initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 39 units.
REASON Blood products, incorrectly tested for the antibodies to
human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2),
were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Adult Manual Resuscitators with Variable Volume Reservoir:
(a) Catalog #008006
(b) Catalog #008006S
(c) Catalog #008006SP
(d) Catalog #008009
(e) Catalog #008106
(f) Catalog #44008-006
(g) Catalog #RESC-1007
(h) Catalog #RESC-1016
(i) Catalog #RESC-1030. Recall #Z-079/087-5.
CODE Lot Numbers: (a) 4A488, 4C694, 4D680
(b) 4A561, 4C345, 4D679
(c) 4A628
(d) 4A302, 4A489, 4B461
(e) 4A562
(f) 4A626, 4E610
(g) 4A485, 4B380, 4B523, 4C516, 4D291, 4D455, 4D566, 4E247
(h) 4B192, 4D350, 4E254, 4E564
(i) 4B381, 4D346.
MANUFACTURER Intertech Resources, Inc., Fort Myers, Florida.
RECALLED BY Manufacturer, by letter August 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, South Africa, Canada, AbuDhabi U.A.
QUANTITY Undetermined.
-7- REASON Associated oxygen tubing may be occluded by excessive
bonding material, thereby preventing or limiting the flow of
oxygen.
SEIZURES:
=================================================================
_______________
PRODUCT Frozen Shrimp (94-557-490 et al).
CHARGE Adulterated - The article consists in part of a decomposed
substance by reason of the presence therein of decomposed
shrimp.
LOCATIONS Americold Cold Storage, Tampa, Florida.
FILED July 19, 1994, U.S. District Court for the Middle District
of Florida, Tampa Division, Civil #94-1131-CIV-T-17C;
FDC #66994.
SEIZED August 1, 1994 - goods valued at approximately $65,541.
_______________
PRODUCT Ultra Slim Diet Nutrition Bars (94-711-111).
CHARGES Adulterated - Valuable constituents, namely Vitamin C and
Riboflavin, have been partly omitted from the article.
Misbranded - The article's labeling is false and misleading
because it represents and suggests that the article provides
30 percent of the U.S. Recommended Daily Allowance (RDA) of
Vitamin C and 33 percent of the U.S. RDA of Riboflavin per
serving; whereas, the article provides from 4.07 to 8.2
percent of the U.S. RDA of Vitamin C and from 16 to 16.6
percent of the U.S. RDA of Riboflavin per serving; and the
nutrition information, ingredients statement, and name and
place of business of the distributor are not prominently
placed on the label with such conspicuousness as to render
them likely to be read by the ordinary individual under
customary conditions of purchase and use because they do not
appear together on the principal display panel or together
without intervening material on the information panel, and
they appear in a type size of less than 1/16-inch in height.
LOCATION Dietary Enterprises, Ltd., doing business as The Diet Store,
Ltd., Niles, Illinois.
FILED November 3, 1994; U.S. District Court for the Northern
District of Illinois; Civil #94C 6593; FDC #67005.
SEIZED November 3, 1994 - goods valued at approximately $9,000.
_______________
PRODUCT Sphygmomanometers and components (94-614-086/093).
CHARGES Adulterated - The strength, purity, or quality of the
sphygmomanometer (Model SB-A900, LOT 001) falls below that
which it purports or is represented to possess, in that the
manometer was inaccurate, exceeding the limitation set
forth; and the methods used in, and the facilities and
controls used for, the articles' (all lots) manufacture,
packing, and storage are not in conformance with the current
good manufacturing practice requirements for devices.
-8- LOCATION Surgical Instrument Company of America, Ridgefield,
New Jersey.
FILED November 2, 1994; U.S. District Court for the District of
New Jersey; Civil #94-5355; FDC #66950.
SEIZED November 3, 1994 - goods valued at approximately $150,000.
_______________
PRODUCT Nifedipine Capsules, USP, 10 and 20 mg (93-675-794, et al).
CHARGES New drug - No approval of a supplement to an application is
in effect for the drug. Adulterated - The methods used in,
and the facilities and controls used for, the article's
manufacture, processing, packing, and holding do not conform
to and are not operated and administered in conformity with
current good manufacturing practice requirements.
LOCATION Chase Laboratories, Newark, New Jersey.
FILED October 14, 1994; U.S. District Court for the District of
New Jersey; Civil #94-4880(NHP); FDC #66914.
SEIZED October 24, 1994 - goods valued at approximately $900,000.
-9-
END OF ENFORCEMENT REPORT FOR NOVEMBER 16, 1994. BLANK PAGES MAY
FOLLOW.
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