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.
April 28, 1999 99-17
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________
PRODUCT
Firewater brand Liquid, (2 (3H) Furanone di-hydro), OTC in 2 and
16 fluid ounce bottles, reportedly intended to be used as a sleep
aid. Recall #D-195-9.
CODE
All lot numbers.
MANUFACTURER
Phillips Pharmatech Labs, Inc., Largo, Florida (contract
MANUFACTURER).
RECALLED BY
Nutritional Concepts, Inc., Davie, Florida, by letter on February
6, 1999. Firm-initiated recall ongoing. See also FDA talk paper
T99-5 dated January 21, 1999.
DISTRIBUTION
California, Florida, Nevada, New Jersey, New Mexico, Texas,
Washington state.
QUANTITY
4,499 16-ounce bottles and 945 2-ounce bottles were distributed.
REASON
Product is an unapproved new drug.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________
PRODUCT
Levothyroxine Sodium Tablets, USP, 0.025 MG; 0.050 MG; 0.075 MG;
0.088 MG; 0.100 MG; 0.112 MG; 0.125 MG; 0.150 MG; 0.175 MG;
0.200 MG; 0.300 MG,. in bottles of 100 and 1,000 tablets,
distributed under various private labels:
Euthryrox - Em Pharma, Div Of Dey Labs
Levothyroxine - Moore
L-Thyroxine Sodium - Major Pharmaceuticals
L-Thyroxine Sodium - Geneva Pharmaceuticals
Levo-T - Pharma Science
Levotec - Technilab
L-Thyroxine Sodium - Harvard Drug
L-Thyroxine Sodium - Logen Pharmaceuticals
L-Thyroxine Sodium - Richie Pharmacal
Euthryrox - Mova Interamerica. Recall #D-174/184-9.
CODE
Any lot number with the prefix(s) MPT, MST, or ST.
MANUFACTURER
Mova Pharmaceutical Corporation, Caguas, Puerto Rico.
RECALLED BY
MANUFACTURER, by letter dated February 25, 1999,
followed by telephone or fax. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
487,275 bottles were distributed.
REASON
Superpotency.
________
PRODUCT
Rx dental anesthetics, in blister packed cartridges:
a) Lidocaine Hydrochloride 2% and Epinephrine Injection,
USP 1:50,000;
b) Lidocaine Hydrochloride 3% and Epinephrine Injection,
USP 1:100,000;
c) Mepivacaine Hydrochloride Injection, USP 3%;
d) Mepivacaine Hydrochloride 2% and Levonordefrin
Injection, USP. 1:20,000. Recall #D-188/191-9.
CODE
PRODUCT LABEL LOT# DATE
Novocol Isocaine 3% 6291A July 1999
7041 October 1999
7158C January 2000
7411A August 2000
8014A September 2000
8028A September 2000
8152 January 2001
8213A February 2001
8274 May 2001
8332B July 2001
8358B July 2001
8359C July 2001
Henry Schein Private Label
6184 March 1999
6291B July 1999
7004A September 1999
7230 April 2000
7308 June 2000
7411B August 2000
7425B August 2000
8028B September 2000
8030A September 2000
8257B May 2001
8275B May 2001
8284B June 2001
8332A July 2001
8358A July 2001
Patterson Private Label
6340 August 1999
7004B September 1999
7156 January 2000
7377A July 2000
7377B July 2000
8014B September 2000
8024A September 2000
8024B September 2000
8276A May 2001
8331B July 2001
Carlisle Private Label
6342 August 1999
7158B January 2000
7231 April 2000
7231A April 2000
7407B August 2000
8214A February 2001
8257A May 2001
8359A July 2001
Meer Private Label
7066A November 1999
8284A June 2001
GENERIC NAME: Lidocaine Hydrochloride and Epinephrine Injection
USP TRADE NAME: Novocol Octocaine 50 and Novocol Octocaine 100
PRODUCT LABEL LOT # EXP DATE
Novocol Octocaine (1:50,000) 7007 September 1998
8006C September 1999
8190C February 2000
8259C May 2000
8280 May 2000
8282B June 2000
8355C July 2000
Patterson Private Label (1:50,000)
7392A July 1999
8086B January 1999
8282A June 2000
Henry Schein Private Label (1:50,000)
7410B August 1999
7410C August 1999
8006B September 1999
8190B February 2000
8259B May 2000
8282C June 2000
8357B July 2000
Carlisle Private Label (1:50,000)
7426B August 1999
8259A May 2000
8355B July 2000
8357A July 2000
Novocol Octocaine (1:100,000)
7175 February 1999
7176 February 1999
7249 April 1999
7259 April 1999
7271 May 1999
7278 May 1999
7285 May 1999
7310 June 1999
7313 June 1999
7314 June 1999
7349 July 1999
7351 July 1999
7358B August 1999
7363 July 1999
7395 July 1999
7399 July 1999
7400 July 1999
7401 July 1999
7413B August 1999
7417 August 1999
8003 September 1999
8004 September 1999
8005 September 1999
8010 September 1999
8011 September 1999
8049 October 1999
8089A November 1999
8099 November 1999
8102 November 1999
8103B November 1999
8115 December 1999
8165A January 2000
8165B January 2000
8233 April 2000
8242 April 2000
8243 April 2000
8244 April 2000
8245 April 2000
8252B May 2000
8267 May 2000
8269B May 2000
8272 May 2000
8288 June 2000
8289 June 2000
8290 June 2000
8291 June 2000
8291A June 2000
8310 June 2000
8311 June 2000
8313 June 2000
8336 July 2000
8337 July 2000
8347 July 2000
8348 July 2000
8349 July 2000
8353 July 2000
8364 August 2000
8365 August 2000
Patterson Private Label (1:100,000)
7170 February 1999
7197 February 1999
7204 March 1999
7225 March 1999
7228B April 1999
7229B April 1999
7325 June 1999
7326 June 1999
7355 July 1999
7357 July 1999
7371 July 1999
7402 August 1999
7403 August 1999
8021 September 1999
8107 November 1999
8166 January 2000
8168 January 2000
8169 January 2000
8171 January 2000
8171A January 2000
8172 January 2000
8184 February 2000
8295 June 2000
8297 June 2000
8339 July 2000
8340 July 2000
8341 July 2000
8342 July 2000
Henry Schein Private Label (1:100,000)
7172 February 1999
7181 February 1999
7183 February 1999
7184 February 1999
7189B February 1999
7214 March 1999
7215 March 1999
7226 March 1999
7283 May 1999
7397 July 1999
7398 July 1999
7416 August 1999
7418 August 1999
7420 August 1999
7421 August 1999
7423B August 1999
8056 October 1999
8128 December 1999
8135 December 1999
8140 December 1999
8176 January 2000
8193 February 2000
8194 February 2000
8195 February 2000
8231 April 2000
8232 April 2000
8237 April 2000
8238 April 2000
8239 April 2000
8240 April 2000
8246 May 2000
8247 May 2000
8248 May 2000
8253 May 2000
8254 May 2000
8255 May 2000
8256 May 2000
8265 May 2000
8266 May 2000
8268 May 2000
8270 May 2000
8271 May 2000
8273 May 2000
8286 June 2000
8287 June 2000
8318 June 2000
8318A June 2000
8326 July 2000
8334 July 2000
8343 July 2000
8344 July 2000
8345 July 2000
8346 July 2000
8350 July 2000
8351 July 2000
8352 July 2000
8361 August 2000
8362 August 2000
Meer Private Label (1:100,000)
7209 March 1999
7419 August 1999
8031 September 1999
8216 February 2000
8241 April 2000
Carlisle Private Label (1:100,000)
7219 March 1999
7224 March 1999
7370 July 1999
7370A July 1999
8023 September 1999
8042B October 1999
8074 January 1999
8080 January 1999
8082 January 1999
8090 January 1999
8180 January 2000
8206 February 2000
8208 February 2000
8294 June 2000
8363 August 2000
GENERIC NAME: Mepivacaine Hydrochloride and Levonordefrin
Injection USP
TRADE NAME: Novocol Isocaine 2%
Novocol Isocaine 2%
7168 February 1999
7301 June 1999
8043B October 1999
8235 April 2000
8236C April 2000
8279C May 2000
8333B July 2000
8360C August 2000
Henry Schein Private Label
7232 April 1999
7408C August 1999
8043C October 1999
8222A February 2000
8277B May 2000
8279B May 2000
8333A July 2000
8360A August 2000
Patterson Private Label
7233B April 1999
8116A December 1999
8116B December 1999
8279A May 2000
8333C July 2000
Carlisle Private Label
7408B August 1999
8222C February 2000
8236B April 2000
8360B August 2000
Meer Private Label
8222B February 2000.
MANUFACTURER
Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario,
Canada.
RECALLED BY
Novocol Pharmaceutical of Canada, Inc., New Castle, Delaware, by
telephone the first week in February 1999, and mailed letters on
February 9, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Undetermined.
REASON
Lack of assurance of sterility.
________
PRODUCT
Oxygen, USP, in D and E size compressed cylinders, Rx.
Recall #D-194-9.
CODE
All lots filled prior to Jan 1, 1999.
MANUFACTURER
Convacare, Inc., Chester, South Carolina.
RECALLED BY
Manufacturer, by visit during routine patient visit beginning on
or about January 20, 1999. Firm-initiated recall complete.
DISTRIBUTION
South Carolina.
QUANTITY
Less than 100 cylinders.
REASON
Current good manufacturing practice violations including but not
limited to lack of calibration for test equipment, odor testing,
and production records.
________
PRODUCT
Trichloroacetic Acid 25% W/V in Purified Water, in 1 fluid ounce
containers, for prescription compounding or repackaging. Recall
#D-196-9.
CODE
Lot #111098D.
MANUFACTURER
Dermatologic Lab & Supply, Inc., Council Bluffs, Iowa.
RECALLED BY
Manufacturer, by telephone on March 15 & 16, 1999, followed by
letter dated March 17, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
New York, Maryland, New Jersey, Ohio, California, Michigan,
Florida, Puerto Rico, Oregon, Tennessee, Texas, Canada.
QUANTITY
52 bottles were distributed.
REASON
Superpotency.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Horizon Pharmaceutical brand Protuss-DM Tablets
(Dextromethorphan Hbr 30 mg, Pseudoephedrine HCl 60mg,
Guaifenesin 600 mg), Sustained-Release, in 100 tablet
bottles, Rx antitussive/decongestant/ expectorant. NDC
#59630-160-10. Recall #D-192-9.
CODE
Lot #T6370J05 EXP 11/00.
MANUFACTURER
Anabolic Laboratories, Inc., Irvine, California.
RECALLED BY
Manufacturer, by letter on January 18, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Undetermined.
QUANTITY
Approximately 2,739 bottles were distributed; firm estimates none
remains on the market.
REASON
Mislabeling - Immediate bottle label incorrectly declares
Pseudoephedrine HCl at 120mg per tablet (correctly
labeled insert shows 60 mg per tablet).
________
PRODUCT
Kaodene non-narcotic liquid for upset stomach and
diarrhea, (30ml Kaolin 3888 mg, Pectin 194.4 mg ...), OTC
in 4 fl. oz. bottles. NDC #0927-0421-12.
Recall #D-193-9.
CODE
Lot #52201.
MANUFACTURER
SSS/Pfeiffer Pharmaceuticals, Atlanta, Georgia.
RECALLED BY
Manufacturer, by letter on March 18, 1999. Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
3,467 units were distributed; firm estimated that 1,500
units remained on market at time of recall initiation.
REASON
Mislabeling - Immediate bottle label declares incorrect
lot number and expiration date (52201 EXP 5 98) bottom of
bottle bears correct lot number and expiration date
(82201 EXP 6/00).
________
PRODUCT
Schein Pharmaceutical brand Valproic Acid Capsules, USP,
250 mg, in 100 capsule bottles, Rx antiepileptic agent.
NDC #0364-0822-01.
Recall #D-197-9.
CODE
Lot numbers: 93502, 93504, 93505,93694 with expiration
date of 11/00.
MANUFACTURER
International Labs, Inc., St. Petersburg, Florida
(repacker/responsible firm).
RECALLED BY
R.P. Scherer Corporation, St. Petersburg, Florida, by
telephone on March 18, 1999, followed by fax on March 19,
1999, and courier delivery on March 22, 1999. Firm-
initiated recall ongoing.
DISTRIBUTION
Undetermined.
QUANTITY
39,728 bottles were distributed.
REASON
Mislabeling - One bottle was found lacking any immediate
bottle label.
________
PRODUCT
Haloperidol Oral Solution, USP, Rx for Dropper Dosage
Only, 2 mg per mL, in 120 mL units, indicated for the
management of manifestations of psychotic disorders, for
Tourette's Disorder in children and adults, and for
treatment of severe behavior problems and hyperactivity
in children, under the Rugby and Barre labels. NDC
#0472-0766-94 and NDC#0536-1011-97. Recall #D-198-9.
CODE
Lot numbers: RP6813 EXP 1/99 and RK7580 EXP 1/99.
MANUFACTURER
Alpharma, U.S. Pharmaceutical Division, Baltimore,
Maryland.
RECALLED BY
Manufacturer, by letter sent on or about January 20,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
29,580 units were distributed.
REASON
Microbial contamination - Product failed specification
for microbial limits test at 12 month stability test
station.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
Blood Grouping Reagent Anti-Jka (Monoclonal) BioClone for Tube
and Microplate Tests, 1 x 3 mL. Recall #B-601-9.
CODE
Lot JAB223A EXP 8/17/98.
MANUFACTURER
Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson Company,
Raritan, New Jersey.
RECALLED BY
Manufacturer, by letter or fax on April 17, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,654 units were distributed.
REASON
Anti-JKA blood grouping reagent exhibited weakened reactivity or
nonreactivity with some Jk(a+b+) red blood cells.
________
PRODUCT
Oncaspar (pegaspargase), in 5 mL vials. Recall #B-642-9.
CODE
Lot numbers: A04806 and A06807.
MANUFACTURER
ENZON, Inc., Piscataway, New Jersey.
RECALLED BY
Rhone-Poulenc Rorer Pharmaceuticals (RPR), Collegeville,
Pennsylvania, by telephone on October 26, 1998, and November 3,
1998, by letter on November 2, 1998, and by fax on November 3,
1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
3,230 vials were distributed.
REASON
Injectable drugs showed an increase in visible particulates in
the product.
________
PRODUCT
Red Blood Cells. Recall #B-655-9.
CODE
Unit #26157-0944.
MANUFACTURER
United Blood Services, Hot Springs, Arkansas.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone and by fax
on January 12, 1999. Firm-initiated recall complete.
DISTRIBUTION
Arkansas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor with a history of
cancer.
________
PRODUCT
Source Plasma. Recall #B-683-9.
CODE
Unit #6010128046.
MANUFACTURER
NABI BioMedical Center, San Antonio, Texas.
RECALLED BY
NABI, Boca Raton, Florida, by fax on November 12, 1998, and by
letter dated November 13, 1998. Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had a tattoo within
12 months of donation.
________
PRODUCT
RhoGAM, Rho(D) Immune Globulin (Human) in pre-filled single dose
syringes. Recall #B-685-9.
CODE
Lots numbers: RHL289A, RHL289B, RHL267A, RHL274A,
RHL274B, RHL281A, RHL281B, RHL281C, RHL288A, RHL288B.
MANUFACTURER
Ortho-Clinical Diagnostics, Inc., A Johnson & Johnson Company,
Raritan, New Jersey.
RECALLED BY
Manufacturer, by telephone on October 15, 1997, and by letter or
fax on October 16, 1997, followed by telephone between October
30, 1997 and November 3, 1997, and by letter on March 6, 1998, or
fax on March 8, 1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide, Austria, England, Hong Kong, Israel.
QUANTITY
Phase I:
Lot RHL289A: 78 packages (100 vials x 1 package)
921 packages (25 vials x 1 package)
Lot RHL289B: 1206 packages (25 vials x 1 package)
Phase II: 211,925 syringes were distributed.
REASON
Rho(D) Immune Globulin demonstrated anti-D levels below the
minimum dose specifications for this product, and were found to
not meet potency specifications.
________
PRODUCT
Red Blood Cells. Recall #B-687-9.
CODE
Unit #10575-9179.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Manufacturer, by telephone on December 1, 1997. Firm-initiated
recall complete.
DISTRIBUTION
Arizona.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose hematocrit
exceeded the acceptable level.
________
PRODUCT
Plasma, Cryo Poor. Recall #B-688-9.
CODE
Unit #10517-0414.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telehone on
September 9, 1996. Firm-initiated recall complete.
DISTRIBUTION
Arizona.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected in a manner that compromised the
sterility of the unit.
________
PRODUCT
Source Plasma. Recall #B-689-9.
CODE
Unit Numbers: G94912-097, G95103-097, G96780-097,
G97255-097.
MANUFACTURER
Alpha Therapeutic Corporation, San Diego, California.
RECALLED BY
Alpha Therapeutic Corporation, Los Angeles, California, by letter
dated July 27, 1998. Firm-initiated recall complete.
DISTRIBUTION
Spain.
QUANTITY
4 units were distributed.
REASON
Blood product was collected from a donor with a history of
hepatitis.
________
PRODUCT
Red Blood Cells. Recall #B-690-9.
CODE
Unit #10517-0310.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on
September 16, 1996, and by letter dated October 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION
Arizona.
QUANTITY
1 unit was distributed.
REASON
Blood product was not quarantined after receiving information
concerning a post donation illness.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-693/694-9.
CODE
Unit #10594-7447.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter and/or fax
dated December 11, 1998, and by telephone on November 20, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Arizona and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of
hepatitis.
________
PRODUCT
Red Blood Cells. Recall #B-695-9.
CODE
Unit numbers: 16LW18304, 16LW18286, 16LW18297.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by letter dated June 9, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
3 units were distributed.
REASON
Blood products were collected from donors whose hematocrits were
below the acceptable level.
________
PRODUCT
Red Blood Cells. Recall #B-696-9.
CODE
Unit numbers: 16KC04241 and 16LY43280.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, letter dated June 10, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Ohio.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from donors whose hematocrits were
below the acceptable level.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-697/698-9.
CODE
Unit numbers: a) 1020971, 1029175, 1036183, 1041836;
b) 1020971, 1036183.
MANUFACTURER
Community Blood Center, Dayton, Ohio.
RECALLED BY
Manufacturer, by letter dated either September 25, 1998 or
October 1, 1998. Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
a) 4 units; b) 2 units were distributed.
REASON
Blood products were collected from a donor who had traveled to an
area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-699/700-9.
CODE
Unit #1039172.
MANUFACTURER
Community Blood Center, Dayton, Ohio.
RECALLED BY
Manufacturer, by letter dated July 13, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Carticel (Autologous Cultured Chondrocytes).
Recall #B-701-9.
CODE
Lot #C60859.
MANUFACTURER
Genzyme- Tissue Repair, Cambridge, Massachusetts.
RECALLED BY
Manufacturer, by telephone on November 25 and 30, 1998, and by
letter dated November 25, 1998. Firm-initiated recall complete.
DISTRIBUTION
Norway.
QUANTITY
1 vial was distributed.
REASON
Tissue repair product was contaminated with Staphylococcus
epidermis (staepi).
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-703/704-9.
CODE
Unit #1528347.
MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by letter dated March 18, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Kentucky and Maryland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had been
incarcerated.
________
PRODUCT
Source Plasma. Recall #B-708-9.
CODE
Unit numbers: 12VCP248, 12VCQ300, 12VCS711.
MANUFACTURER
Collection Facility: Centeon Bio-Services, Inc., Indianapolis,
Indiana.
Error Occurred At: Centeon Bio-Services, Inc., Lexington,
Kentucky.
RECALLED BY
Centeon Bio-Services, Inc., Knoxville, by letter dated April 6,
1998. Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
3 units were distributed.
REASON
Blood products were collected from an unsuitable donor.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells. Recall #B-691-9.
CODE
Unit numbers: 10535-4696, 10535-4697, 10535-6330.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on
September 7, 1998. Firm-initiated recall complete.
DISTRIBUTION
Arizona.
QUANTITY
3 units were distributed.
REASON
Blood products were stored at unacceptable temperatures.
________
PRODUCT
Red Blood Cells. Recall #B-692-9.
CODE
Unit #10584-0903.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on April
15, 1998. Firm-initiated recall complete.
DISTRIBUTION
Arizona.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells. Recall #B-705-9.
CODE
Unit #8044681.
MANUFACTURER
LifeShare, Inc., Elyria, Ohio.
RECALLED BY
Manufacturer, by telephone on February 1, 1999, and by letter
dated February 23, 1999. Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells. Recall #B-706-9.
CODE
Unit #8051190.
MANUFACTURER
LifeShare, Inc., Elyria, Ohio.
RECALLED BY
Manufacturer, by letter dated February 26, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells. Recall #B-707-9.
CODE
Unit #16LS44645.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by telephone and letter on March 9, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Gamma-clone Anti-D (Monoclonal-Polyclonal Blend) Blood Grouping
Reagent. Recall #B-711-9.
CODE
Lots DM80-1 and DM80-2 - EXP June 24, 1999,
Lots DM81-1 and DM81-2 - EXP August 12, 1999.
MANUFACTURER
Gamma Biologicals, Inc., Houston, Texas.
RECALLED BY
Manufacturer, by letter dated Novemer 30, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
26,880 vials of lots DM80-1 and DM80-2; 26,489 vials of lots
DM81-1 and DM81-2 were distributed.
REASON
Blood Grouping Reagents have progressively lost potency during
storage.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
Poly Per-Q-Cath Single Lumen Catheters:
a) Catalog No. 3133100, 3 Fr. Poly Per-Q-Cath PICC w/
Intermediate Tray;
b) Catalog No. 3133105, 3 Fr. Poly Per-Q-Cath PICC w/ Basic Tray;
c) Catalog No. 3133130, 3 Fr. Poly Per-Q-Cath Midline w/
Insertion Tray;
d) Catalog No. 3133135, 3 Fr. Poly Per-Q-Cath Midline w/
Introducer Only;
e) Catalog No. 3134100, 4 Fr. Poly Per-Q-Cath PICC w/
Intermediate Tray;
f) Catalog No. 3134105, 4 Fr. Poly Per-Q-Cath PICC w/ Basic Tray;
g) Catalog No. 3134130, 4 Fr. Poly Per-Q-Cath Midline w/
Insertion Tray;
h) Catalog No. 3134135, 4 Fr. Poly Per-Q-Cath Midline w/
Introducer Only;
i) Catalog No. 3135100, 5 Fr. Poly Per-Q-Cath PICC w/
Intermediate Tray;
j) Catalog No. 3135105, 5 Fr. Poly Per-Q-Cath PICC w/Basic Tray;
k) Catalog No. 3135135, 5 Fr. Poly Per-Q-Cath Midline w/
Introducer Only. Recall #Z-806/816-9.
CODE
All Lot Numbers.
MANUFACTURER
Gesco International, Inc., San Antonio, Texas.
RECALLED BY
Bard Access Systems, Inc., Salt Lake City, Utah, by letter mailed
March 24, 1999. Firm-initiated recall complete.
DISTRIBUTION
Nationwide, Canada, Asia.
QUANTITY
1,815 units were distributed.
REASON
The catheters may leak near the hub in the area of skin
insertion.
________
PRODUCT
Hamilton Disposable Precision Tips, a Microlab AT Series
Instrument, a pipette used to aspirate and dispense fluid
including blood products: a) Model 235300; b) 235400.
Recall #Z-818/819-9.
CODE
42798P6 52798P6 62798P6 72798P6 12898P6
22898P6 32898P6 42898P6 52898P6 62898P6
72898P6 12998P6 22998P6 32998P6 42998P6
52998P6 62998P6 72998P6 13098P6 23098P6
33098P6 43098P6 53098P6 63098P6 73098P6
13198P6 23198P6 33198P6 43198P6 53198P6
63198P6 73198P6 13298P6 23298P6 33298P6
43298P6 53298P6 63298P6 73298P6 13398P6
23398P6 33398P6 43398P6 53398P6 63398P6
73398P6 13498P6 23498P6 33498P6 43498P6
53498P6 63498P6 73498P6 13598P6 23598P6
33598P6 43598P6 53598P6 63598P6 23698P6
33698P6 43698P6 53698P6 63698P6 73698P6
13798P6 23798P6 33798P6 43798P6 53798P6
63798P6 73798P6 13898P6 23898P6 33898P6
43898P6 53898P6 63898P6 73898P6 13998P6
23998P6 33998P6 43998P6 53998P6 63998P6
73998P6 14098P6 24098P6 34098P6 44098P6
54098P6 64098P6 74098P6 14198P6 24198P6
34198P6 44198P6 54198P6 64198P6 74198P6
14298P6 24298P6 34298P6 44298P6 54298P6
64298P6 74298P6 14398P6 24398P6 34398P6
44398P6 54398P6 64398P6 74398P6 14498P6
24498P6 34498P6 44498P6 54498P6 74498P6
14598P6 24598P6 34598P6 44598P6 54598P6
64598P6 74598P6 14698P6 24698P6 34698P6
44798P6 64798P6 74798P6 14898P6 74898P6
14998P6 24998P6 34998P6 44998P6 54998P6
64998P6 74998P6 15098P6 25098P6 35098P6
45098P6 55098P6 65098P6 75098P6 15198P6
25198P6 35198P6 45198P6 65198P6 75198P6
15298P6 25298P6 35298P6 45298P6 75298P6
15398P6 25398P6 35398P6 45398P6 55398P6
60199P6 70199P6 10299P6 20299P6 30299P6
40299P6 50299P6 60299P6 70299P6 10399P6
20399P6 30399P6 40399P6 50399P6 60399P6
70399P6 10499P6 20499P6 30499P6 40499P6
50499P6 60499P6 70499P6 10599P6 20599P6
30599P6 50599P6 60599P6 70599P6 10699P6
20699P6 40699P6 60699P6 70699P6 20799P6
30799P6 40799P6 50799P6 60799P6 70799P6
10899P6 30899P6 40899P6 50899P6 60899P6
70899P6 10999P6 20999P6 30999P6 60999P6
31099P6 61099P6 71099P6 11199P6 21199P6
42998P5 52998P5 62998P5 72998P5 13098P5
23098P5 33098P5 43098P5 53098P5 63098P5
73098P5 13198P5 23198P5 33198P5 43198P5
53198P5 63198P5 73198P5 13298P5 23298P5
33298P5.
MANUFACTURER
Hamilton Company, Reno, Nevada.
Hamilton Disposable Precision Tips are molded exclusively
contracted by: Tech Group Tempe, Arizona.
RECALLED BY
Hamilton Company, Reno, Nevada, by fax and letter on April 5,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,954 cases were distributed.
REASON
There is a defect in the molding of the plunger.
________
PRODUCT
MXR-2000 Flowmeter, used to administer an analgesic agent for
conscious sedation: a) Model 2050; b) Model 2055.
Recall #Z-820/821-9.
CODE
Serial numbers: a) 1966-2021; b) 3733-3957.
MANUFACTURER
Porter Instrument Company, Inc., Hatfield, Pennsylvania.
RECALLED BY
Manufacturer, by letter March 18, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
238 units were distributed.
REASON
Mounting screws were defective and found to have brittle
fractures after final assembly and testing.
________
PRODUCT
Jackson Esophageal Dilator 14F, Catalog numbers: 50-7808, 50-
7809, 50-7810, 50-7812, 50-7814, 50-7816, 50-7818.
Recall #Z-822/828-9.
CODE
Lots included in the recall are AA8 through KK8.
MANUFACTURER
Device Resources Corporations, Lake Bluff, Illinois.
RECALLED BY
Pilling Weck Surgical, Fort Washington, Pennsylvania, by
telephone on December 11, 1998, followed by letter on December
18, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Canada, Singapore.
QUANTITY
407 devices were distributed.
REASON
Esophageal dilator tips come off the metal shaft.
_______
UPDATE
Recall #Z-766/771-9, BARD 6 F Envision Pigtail Cardiovascular
Angiographic Catheters, listed in the March 31, 1999 Enforcement
Report should read:
RECALLED BY: Medtronic/AVE, Billerica,
Massachusetts.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - - CLASS II
________
PRODUCT
American Protein Corporation Steamed Bone Meal in 50 pound bags;
American Meat Protein Corp. Steamed Bonemeal, 2,000 pound tote
bags. Recall #V-047-9.
CODE
All product not bearing the caution statement required by 21 CFR
589.2000.
MANUFACTURER
AMPC, Inc., Lytton, Iowa.
RECALLED BY
AMPC, Inc., Ames, Iowa, by telephone on February 25, 1999, and
March 8, 1999, followed by letter on March 2, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Nationwide, Taiwan, Canada.
QUANTITY
Approximately 125-175 tons were produced weekly since 1997 and
distributed.
REASON
Product contained protein derived from mammalian tissue and
according to regulation must bear the statement "Do not feed to
cattle or other ruminants" on the label. This regulation is
designed to prevent the establishment and amplification of BSE
through feed. This statement did not appear on the labeling.
END OF ENFORCEMENT REPORT FOR APRIL 28, 1999.
####
![[FDA HOME PAGE]](https://webarchive.library.unt.edu/eot2008/20090119131742im_/http://www.fda.gov/icon/iconhome.gif)