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
05/14/1991
FDA Enforcement for the week of 5/15/91
FDA ENFORCEMENT REPORT
FOR MAY 15, 1991
May 15, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Product: (a) Low Moisture Mozzarella Cheese;
(b) Low-Moisture-Part Skim Mozzarella Cheese.
Recall #F-373/374-1.
Code: Cheese dated January 25, 1991 through February 12, 1991.
Manufacturer: B.C. Acquisitions, Inc., doing business as Branch
Cheese, Branch, Wisconsin.
Recalled by: Manufacturer, by telephone February 14, 1991 and
March 6, 1991. Firm-initiated recall ongoing.
Distribution: Connecticut, Georgia, Illinois, Michigan, New York,
Ohio, Pennsylvania, Texas, West Virginia, Wisconsin.
Quantity: 6,553 cases and 89/1,000 pound totes were distributed.
Reason: Product is contaminated with Listeria monocytogenes.
----
-1-
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Mini Jelly Cups, a gelatin like candy. Recall #F-378-1.
Code: None
Manufacturer: Pokka Corporation (S) PTE. LTD, Jurong Town, Singapore.
Recalled by: Tan Duc Trading, Brooklyn, New York, by telephone January
19, 1991. Firm-initiated recall ongoing.
Distribution: New York, Massachusetts.
Quantity: 95 cartons were distributed; firm estimates 12 cartons
remain on the market.
Reason: Product contains undeclared FD&C Yellow No. 5 along with
non-permitted food color cochineal Red or Ponceau 4R.
----
Product: New York Bagel Boys brand Egg Bagels packed 12 bagels in
plastic bag. Recall #F-377-1.
Code: An orange bag closure is used. Orange closure indicates
product was manufactured Monday, March 25, 1991.
Manufacturer: General Bagel Corporation, Bothell, Washington.
Recalled by: Manufacturer, by telephone on March 27, 1991, followed
by visit on March 28, 1991. Firm-initiated recall ongoing.
Distribution: Washington state.
Quantity: 53 dozen were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: (a) Silver Creek brand Canned Smoked Sturgeon, in 4 ounce
cans; (b) Canned Smoked Salmon, in 4 ounce cans.
Recall #F-375/376-1.
Code: (a) Not coded; (b) 26290104.
Manufacturer: Truzzolino's Food Products, Butte, Montana.
Recalled by: Tunnel Creek, Inc., Twin Falls, Idaho, by telephone
and visit October 26, 1990. Firm-initiated recall ongoing.
Distribution: Washington state, Florida, Idaho.
Quantity: (a) 64 cans; (b) 64 cans were distributed.
Reason: Product processed without having a field scheduled process.
----
COSMETICS
NONE
-2-
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Trilafon Tablets and Etrafon Tablets, immediate
release coated tablets, packed in 100, and 500 tablet
bottles. The Etrafon tablets are also packed in 100
tablet/unit dose packs:
(a-d) Trilafon Tablets (Perphenazine), USP - All strengths
2 mg, 4 mg, 8 mg and 16 mg, an Rx product used in the
treatment of psychotic disorders and to control severe
nausea and vomiting in adults;
Etrafon is an Rx product prescribed for patients with
severe anxiety and in a depressed mental state:
(e) Etrafon Tablets, USP 2/25 - Each tablet contains
Perphenazine, USP - 2 mg; and Amitriptyline HCl, USP - 25 mg.
(f) Etrafon 2-10 Tablets, USP 2/10 - Each tablet contains
Perphenazine, USP - 2 mg; and Amitriptyline HCl, USP - 10 mg.
(g) Etrafon Forte Tablets, USP 4/25 - Each tablet contains
Perphenazine, USP - 4 mg; and Amitriptyline HCl, USP - 25 mg.
(h) Etrafon A Tablets, USP 4/10 - Each tablet contains
Perphenazine, USP - 4 mg; and Amitriptyline HCl, USP - 10 mg.
Recall #D-402/409-1.
Code: Batch Numbers:
(a) Trilafon (perphenazine) Tablets, 2 mg:
6-ADH-1, EXP 1/91 6-ADH-107, EXP 9/91 8-ADH-3, EXP 3/93
6-ADH-2, EXP 3/91 6-ADH-108, EXP 9/91 8-ADH-4, EXP 5/91
6-ADH-3, EXP 3/91 7-ADH-1, EXP 8/91 8-ADH-5, EXP 5/91
6-ADH-101, EXP 3/91 7-ADH-2, EXP 12/91 9-ADH-1, EXP 3/92
6-ADH-102, EXP 4/91 7-ADH-3, EXP 12/91 9-ADH-4, EXP 10/92
6-ADH-103, EXP 5/91 7-ADH-4, EXP 3/92 0-ADH-1, EXP 3/93
6-ADH-104, EXP 5/91 7-ADH-101, EXP 3/92 0-ADH-2, EXP 4/93
6-ADH-105, EXP 7/91 8-ADH-1, EXP 1/93
6-ADH-106, EXP 9/91 8-ADH-2, EXP 1/93
(b) Trilafon (Perphenazine) Tablets, 4 mg:
6-ADK-1, EXP 1/91 7-ADK-1, EXP 10/92 8-ADK-2, EXP 3/93
6-ADK-2, EXP 3/91 7-ADK-2, EXP 3/92 8-ADK-3, EXP 3/93 9-ADK-1, EXP 3/92
6-ADK-3, EXP 3/91 7-ADK-101, EXP 9/92 8-ADK-4, EXP 5/91 9-ADK-2, EXP 3/92
6-ADK-4, EXP 4/91 7-ADK-102, EXP 3/92 8-ADK-5, EXP 5/91 9-ADK-3, EXP 9/92
6-ADK-5, EXP 7/91 7-ADK-103,EXP 11/92 8-ADK-6, EXP 7/91 0-ADK-1, EXP 3/93
6-ADK-6, EXP 9/91 7-ADK-104,EXP 12/92 8-ADK-7, EXP 9/91 0-ADK-3, EXP 5/92
6-ADK-101,EXP 3/91 8-ADK-1, EXP 1/93 8-ADK-8, EXP 9/91
8-ADK-9,EXP 9/91 or 9/90
8-ADK-10,EXP 12/91
(c) Trilafon (perphenazine) Tablets, 8 mg:
6-ADJ-1, EXP 1/91 7-ADJ-101, EXP 9/92 8-ADJ-6, EXP 7/91
6-ADJ-2, EXP 6/91 7-ADJ-102, EXP 10/92 8-ADJ-7, EXP 9/91
6-ADJ-3, EXP 7/91 7-ADJ-103, EXP 11/92 8-ADJ-8, EXP 9/91
6-ADJ-101, EXP 7/91 7-ADJ-104, EXP 11/92 8-ADJ-9, EXP 9/91 or 9/90
-3-
6-ADJ-102, EXP 9/91 8-ADJ-1, EXP 1/93 8-ADJ-10, EXP 8/91
6-ADJ-103, EXP 10/91 8-ADJ-2, EXP 3/93 8-ADJ-11, EXP 12/91 or 12/90
6-ADJ-104, EXP 1/91 8-ADJ-3, EXP 3/93 8-ADJ-12, EXP 11/91
7-ADJ-1, EXP 12/91 8-ADJ-4, EXP 5/91 9-ADJ-10, EXP 9/92
7-ADJ-2, EXP 3/92 8-ADJ-5, EXP 5/91 9-ADJ-12, EXP 10/92
9-ADJ-1, EXP 3/92
9-ADJ-2, EXP 9/92
0-ADJ-1, EXP 4/93
(d) Trilafon (perphenazine) Tablets, 16 mg:
6-ADM-1, EXP 1/91 7-ADM-1, EXP 1/92 8-ADM-1, EXP 1/93
6-ADM-2, EXP 1/91 7-ADM-2, EXP 1/92 8-ADM-2, EXP 3/93
6-ADM-3, EXP 5/91 7-ADM-3, EXP 4/92 8-ADM-3, EXP 3/93
6-ADM-4, EXP 5/91 7-ADM-4, EXP 4/92 8-ADM-4, EXP 5/91
6-ADM-5, EXP 7/91 7-ADM-5, EXP 4/92 8-ADM-5, EXP 5/91
6-ADM-6, EXP 8/91 7-ADM-6, EXP 10/92 8-ADM-6, EXP 7/91
6-ADM-7, EXP 8/91 7-ADM-101, EXP 4/92 9-ADM-1, EXP 1/92
6-ADM-101, EXP 2/91 9-ADM-2, EXP 4/92
6-ADM-102, EXP 2/91 0-ADM-2, EXP 2/93
6-ADM-103, EXP 4/91
6-ADM-104, EXP 4/91
(e) ETRAFON 2-10, 2/10MG TABLETS:
8-ANA-1, EXP 1/91
8-ANA-2, EXP 3/91
9-ANA-1, EXP 1/92
(f) ETRAFON, 2/25MG TABLETS:
8-ANC-1, EXP 2/91
8-ANC-2, EXP 6/91
9-ANC-1, EXP 9/92
(g) ETRAFON A, 4/10MG TABLETS:
9-ANB-1, EXP 1/92,
9-ANB-2, EXP 6/92
9-ANB-3, EXP 9/92
0-ANB-1, EXP 2/92
(h) ETRAFON FORTE, 2/25MG TABLETS:
8-ANE-101, EXP 6/91
8-ANE-1, EXP 2/91
0-ANE-1, EXP 4/92
Manufacturer: Schering Plough Corporation, Kenilworth, New Jersey.
Recalled by: Schering Laboratories, Inc., Union, New Jersey, by
letter January 23, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately (a) 28 million tablets; (b) 2 million tablets
were distributed.
Reason: Some lots fail dissolution specifications, others lack
assurance of meeting specificatons through expiration date.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-198/202-1.
-4-
Code: Unit numbers: (a) 17F60075, 17G77735, 17H31920, 17H39657,
17H44384, 17J41878, 17K72889, 17K79829, 17M76005, 17M84182,
17P11630, 17Q25860, 17Q36163, 17R33969, 17R45737;
(b) 17F60075, 17G77735, 17H31920, 17H39657, 17M76005,
17M84182, 17P11630, 17Q25860, 17Q36163, 17R33969;
(c) 17K72889;
(d) 17K79829, 17M84182, 17Q36163, 17R45737;
(e) 17F60075, 17G54452, 17G77735, 17H31920, 17H39657,
17H44384, 17J33645, 17J41878, 17K72289, 17M76005,
17P11630, 17P13748, 17Q25860, 17R33969.
Manufacturer: American Red Cross, St. Paul, Minnesota.
Recalled by: Manufacturer, by letters of May 21, 25, 29 and 31, 1990,
June 1, 6 and 8, 1990, September 6 and 9, 1990; and
November 9, 1990 and by telephone May 29, 1990,
August 28, 1990 and September 6, 1990. Firm-initiated
recall ongoing.
Distribution: Minnesota, Massachusetts, Tennessee, California
Wisconsin, Switzerland.
Quantity: (a) 15 units; (b) 10 units; (c) 1 unit;
(d) 4 units; (e) 14 units.
Reason: Blood products were collected and distributed from
donors who: 1) previously tested repeatably
reactive for the antibody to the human immuno-
deficiency virus type-1 (anti-HIV-1); 2) had spouses
that participated in high risk behavior; 3) were IV
drug users; or 4) had histories of hepatitis.
----
Product: Red Blood Cells. Recall #B-224-1.
Code: Unit #38T30383.
Manufacturer: American Red Cross Blood Services, Fort Wayne,
Indiana.
Recalled by: Manufacturer, by telephone August 31, 1990. Firm-
initiated recall complete.
Distribution: Indiana.
Quantity: 1 unit.
Reason: Blood product collected from a donor who was
subsequently diagnosed as having a gum infection
at the time of donation was distributed.
----
Product: (a) Red Blood; (b) Recovered Plasma. Recall #B-234/235-1.
Code: Unit #53R53398.
Manufacturer: American Red Cross, Baltimore Maryland.
Recalled by: Manufacturer, (a) by telephone August 28, 1990 followed
by letter dated January 18, 1991; (b) by letter dated
November 14, 1990. Firm-initiated recall ongoing.
Distribution: (a) Maryland; (b) Switzerland.
Quantity: 1 unit of each component.
-5-
Reason: Blood products which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from a donor who previously tested repeatably
reactive for anti-HIV-1, were distributed.
----
Product: Recovered Plasma. Recall # B-236-1.
Code: Unit# 4742270.
Manufacturer: Memorial Sloan Kettering Cancer Center, New York, New York.
Recalled by: Manufacturer, by telephone followed by letter October 2, 1990
and by telephone and letter December 5, 1990. Firm-
initiated recall complete.
Distribution: New Jersey, Florida, Switzerland.
Quantity: 1 unit.
Reason: Recovered Plasma, collected from a donor who previously
tested repeatably reactive for Human Immunodeficiency Virus
Type 1 (anti-HIV-1), was distributed.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-237/238-1.
Code: Unit numbers: 40FK21979, 40GR97973.
Manufacturer: American Red Cross, Peoria, Illinois.
Recalled by: Manufacturer, by letters of January 7 and 31, 1991.
Firm-initiated recall ongoing.
Distribution: (a) Illinois; (b) California.
Quantity: 2 units of each component.
Reason: Blood products collected from a donor diagnosed
with cancer, were distributed.
----
CORRECTION: Intal Nebulizer Solution, 2 ml ampules, Recall #D-401-1
Which appeared in the May 1, 1991 Enforcement Report
should read:
Recalled by: Fisons Corporation, Rochester, New York, by
telephone March 15, 1991, FAX March 18, 1991 and by
letter March 22, 1991.
Quantity: 27 boxes (120 ampules per box) were distributed.
----
Class III -
Product: Fred Meyer Certified brand Children's Chewable Non-
Aspirin Pain Relief, 80 mg, an OTC product.
Recall #D-410-1.
Code: Lot numbers H0080J EXP 8/92, J0135C EXP 9/92.
Manufacturer: Hall Laboratories, Inc., Portland, Oregon.
Recalled by: Manufacturer, by telephone April 2 and 19, 1991.
Firm-initiated recall ongoing.
-6-
Distribution: Oregon, Washington state, Alaska, Idaho.
Quantity: 13,963 boxes of 30 tablets each were distributed.
Reason: The unit carton incorrectly states dosage for 2-3
year old as 3 tablets. The correct dosage of 2 tablets
appears on the label.
----
Product: Furosemide Tablets, an Rx diuretic and anti-hypertensive:
(a) 20 mg Tablets, in bottles of 100 and 1,000;
(b) 40 mg Tablets, in bottles of 100 and 500;
(c) 80 mg Tablets, in bottles of 100. Recall #D-411/413-1.
Code: Lot numbers: (a) 19579L EXP 9/91, 27899L EXP 9/91,
395D9L EXP 12/91 (100's); 13310L EXP 2/91, 16711L EXP 10/92
19679L EXP 7/91, 21630L EXP 3/92, 27799L EXP 9/91,
397D9L EXP 1/92 (1000's);
(b) 17169L (100's); 13410L EXP 1/92, 17069L EXP 6/91
17169L EXP 6/91, 18011L EXP 12/92, 20479L EXP 7/91,
25540L EXP 6/92, 34650L EXP 5/92, 34750L EXP 5/92,
34950L EXP 6/92, 32309L EXP 10/91, 38060L EXP 6/92,
57590L EXP 9/92;
(c) 13610L EXP 2/92, 16420L EXP 2/92, 43170L EXP 8/92,
27999L EXP 10/91.
Manufacturer: Warner Chilcott Labs, Lititz, Pennsylvania.
Recalled by: Warner Chilcott, Division of Warner Lambert, Morris
Plains, New Jersey, by letter April 12, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 127,860 bottles were distributed.
Reason: Product may not meet dissolution specifications through
expiration date.
----
Product: Isovue 300 (Iopamidol Injection), in 75 ml clear
glass bottles, an Rx product for intravenous diagnostic
imaging. Recall #D-414-1.
Code: Lot #1B48177 EXP 2/1/94.
Manufacturer: Bristol-Myers Squibb Company, New Brunswick, New Jersey.
Recalled by: Squibb Diagnostics, Princeton, New Jersey, by letter
March 26, 1991. Firm-initiated recall ongoing.
Distribution: California, Georgia, Iowa, Illinois, Indiana, Massachusetts,
Maryland, Michigan, North Carolina, Nebraska, North Dakota,
New Jersey, Oklahoma, Pennsylvania, Wisconsin.
Quantity: 810 bottles were distributed; firm estimates 320
bottles remain on the market.
Reason: The primary labeling panel correctly identifies the
product as Isovue 300. The secondary identification
which appears along the bottom of the label, incorrectly
identifies the product as Isovue-370.
----
-7-
Product: Abbott Pharmaceuticals brand Dicumarol Tablets, USP,
50 mg, an Rx oral coumarin anticoagulant for the
prophylaxis and treatment of blood clots, in bottles
of 100 and 1,000 tablets. Recall #D-415-1.
Code: Lot numbers: 03-386-AY-40 EXP 5/1/92, 03-386-AY-21
EXP 5/1/92, 16-451-AY-21 EXP 6/1/93.
Manufacturer: Abbott Laboratories, Barceloneta, Puerto Rico.
Recalled by: Abbott Laboratories, Abbott Park, Illinois, by letter
April 12, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 4,240 bottles of 100 and 66 bottles of 1000 were
distributed; firm estimates very little of the
product remains on the market.
Reason: Product may not meet dissolution specifications through
expiration date.
----
Product: Red Blood Cells. Recall #B-183-1.
Code: Unit #6016238.
Manufacturer: LifeSource, Glenview, Illinois.
Recalled by: Manufacturer, telephone August 1, 1990. Firm-initiated
recall complete.
Distribution: Illinois.
Quantity: 1 unit.
Reason: Blood product labeled with an incorrect expiration date.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Johnson & Johnson Reach Full Size Gentle Toothbrush.
Recall #Z-557-1.
Code: Product #7118 - Lot numbers: DOP, EOP, GOP, HOP, JOP, KOP.
Corrugated shipper date codes first 3 digits 091 through
270.
Product #7117 - Lot numbers: 4DOP, 4EOP, 4GOP, 4HOP,
4JOP, 4KOP. Shipper date codes first 3 digits 091
through 243.
Manufacturer: Johnson & Johnson Dental Care Company, Las Piedras,
Puerto Rico.
Recalled by: Johnson & Johnson Consumer Products, Inc., Skillman,
New Jersey, by letters of February 15, 1991 and
April 22, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and Puerto Rico.
-8-
Quantity: 1.7 million units (less 2,856 - code 7117) were
distributed; firm estimates 320,000 units remain
on the market.
Reason: Broken handles.
----
Product: Intravascular (IV) Administration Sets, with piggyback
feature, used for Secondary Infusion of IV Fluids:
Recall Nos. Z-610/645-1
1. V1419-17 15 Drops/mL IV Set with 2 Injection Sites and 2
Check Valves;
2. V1443 15 Drops/mL ADDitIV Primary IV Set with 2 Injection
Sites; 86" Length; w/V-Clamp;
3. V1445 Drops/mL ADDitIV Primary IV Set with 3 Injection
Sites; 96" Length; w/V-Roller Clamp;
4. V1445-24 15 Drops/mL ADDitIV Primary IV Set with 4
Injection Sites;
5. V1445-30 15 Drops/mL ADDitIV Primary IV Set with 3
Injection Sites; 118" Length; w/Roller Clamp;
6. V1446 15 Drops/mL ADDitIV Primary IV Set with 2 Injection
Sites; 93" Length; w/V-Clamp;
7. V1448 60 Drops/mL ADDitIV Primary IV Set with 3 Injection
Sites; 87" Length; w/V-Clamp;
8. V1449-01 60 Drops/mL ADDitIV Primary Mini-Drop Vented IV
Set wi th 3 Injection Sites; 89" Length; w/Roller Clamp;
9. V1449-12 60 Drops/mL ADDitIV Primary Mini-Drop
vented IV Set with 2 Injection Sites;
10. V1451 60 Drops/mL ADDitIV Primary Mini-Drop IV Set
with 3 Injection Sites; 89" Length; w/Roller Clamp;
11. V1453 15 Drops/mL ADDitIV Primary IV Set with 3
Injection Sites; 96" Length; w/V-Clamp;
12. V1464-15 15 Drops/mL ADDitIV Primary IV Set with 2
Injection Sites; 88" Length; w/Roller Clamp;
13. V1486 60 Drops/mL ADDitIV Primary IV Set with 3
Injection Sites; 87" Length; w/Roller Clamp;
14. V1776 15 Drops/mL ADDitIV Primary IV Set with PMF Filter
and 3 Injection Sites;
15. V1776-40 15 Drops/mL ADDitIV Primary IV Set with
pre-attached Secondary Set with PMF Filter and 2
Injection Sites;
16. V1778 60 Drops/mL ADDitIV Primary Mini-Drop IV Set with
PMF Filter and 3 Injection Sites;
17. V1782 15 Drops/mL ADDitIV Primary IV Set with 3
Injection Sites and Low Pressure Trimed Filter (0.22)
Pressure Rating: 20 psi; 87" Length; w/Roller Clamp and Side
Clamp;
18. V1778 60 Drops/mL ADDitIV Primary Mini-Drop IV Set with
PMF Filter and 3 Injection Sites;
19. V1787 60 Drops/mL ADDitIV Primary IV Set with 3
Injection Sites and Low Pressure Trimed Filter (0.22)
Pressure Rating: 20 psi; 87" Length; w/Roller Clamp & Side
Clamp;
-9-
20. V1788 60 Drops/mL ADDitIV Primary Mini-Drop IV Set with
Low Pressure Trimed Filter (0.22) 3 Injection Sites
Pressure Rating: 20 psi; 81" Length; w/V-Clamp;
21. V5405 Extension Set with 2 Injection Sites and Check
Valve;
22. V7210* 15 Drops/mL Intelligent Pump Primary Additive IV
Set with Check Valve, Nonvented; 130" Length; w/Roller
Clamp. (*May appear as Cat. Nos. C7210-83 or V7210-83 on
the label).
23. V7215 15 Drops/mL Intelligent Pump Measured Volume
Primary Additive Set with Check Valve and Low Pressure
Trimed Filter (0.22), Nonvented; 129" Length;
24. V7220 15 Drops/mL Intelligent Pump Measured Volume
Primary Additive Set with 150 mL Buret No Automatic
Shutoff;
25. V7225 15 Drops/mL Intelligent Pump Primary Additive IV
Set with Check Valve, Nonvented;
26. V7230 15 Drops/mL Intelligent Pump Primary Additive IV
Set with Check Valve, Vented; 130" Length; w/Roller Clamp;
27. V7230-14 15 Drops/mL Intelligent Pump Primary Additive
IV Set with Check Valve, Vented; 130" Length; w/Roller
Clamp & Ball Valve;
28. V7235 15 Drops/mL Intelligent Pump Primary Additive IV
Set with Check Valve and Low Pressure Trimed Filter
(0.22), Vented; 129" Length; w/Roller Clamp;
29. V7235-14 15 Drops/mL Intelligent Pump Primary Additive
IV Set with Check Va1ve and Low Pressure Trimed Filter
(0.22), Vented; 129" Length; w/Roller Clamp & Ball Valve;
30. V8600 15 Drops/mL AccuPro Pump Additive IV Set with 2
Injection Sites;
31. V8610 15 Drops/mL AccuPro Pump Additive IV Set with 3
Injection Sites;
32. V8623 60 Drops/mL AccuPro Pump Mini-Drop Additive IV
Set;
33. V8631 15 Drops/mL AccuPro Pump Vented Additive IV Set
with 2 Injection Sites;
34. V8720 15 Drops/mL AccuPro Pump Additive IV Set with
Trimed Filter (0.22) and 3 Injection Sites Filter
Pressure Rating: 50 psi;
35. V8730 15 Drops/mL AccuPro Pump Primary Vented IV Set
with Trimed Filter (0.22) and 3 Injection Sites Filter
Pressure Rating: 50 psi;
36. V0218 20 Drops/mL Intellegent Pump Primary Additive IV
Set w/Ball Drip Chamber, Nonvented.
Code: Lot numbers: 1. F0C179
2. F9N133, F9P007, F0P241, F9P279, F9P005, F9S217,
F9S218, F9S219, FOA104, F0A332, F0A340, FOB051,
F0B091, F0B357, FOC086, FOC087, FOC121, F0C156,
F0C157, F0D005, F0D033, F0D065, F0E111, F0E145,
FOH038, F0H072, F0H102, F0J008, F0H050, F0H096,
FOJ142, FOK004, F0K017, F0K066, F0K114, F0K161,
FOL077, F0L177, F0L152, F0N050, F0N081, FON121,
F0N157, F0P008, F0E079, F0H007, F9P321
-10-
3. F9N134, F9P234, F9P294, F9S325, F0A105, F0A148,
F0A182, F0B002, F0B093, F0C158, F0D006, F0D034,
F0D066, F0E008, F0E047, F0E080, F0E112, F0E146,
F0H008, F0H039, FOH073, F0H103, F0H292, FOH009,
FOJ051, F0J097, F0K018, F0K067, F0K115, F0K162,
F0L047, F0L118, F0L153, F0N051, F0N082, F0N122,
F0N158, F0P009, F0L078
4. F0L400
5. F9S326, F0D021, F0S053, F0J133, F0K048, F0L104,
F0N109
6. F9N147, F9N148, F0S263, F0B053, F0D049, F0E066,
F0J031, F0J161, F0L134, F0L397, F0N101, F0N144,
F0P024, F0H055
7. F9N112, F9P008, F0A106, F0B054, F0B132, F0B358,
F0C013, F0C089, F0C123, F0C159, F0D067, F0E081,
F0H009, F0H074, F0H010, F0H052, F0H098, F0J143,
F0K019, F0K068, FOK116, F0K163, F0L079, F0L119,
F0L154, F0N083, F0N123, F0N159, F0P042, F0E113,
8. F9P009, F9S009, F0A049, F0A107, F0A149, F0B003,
FOB055, F0B094, FOB133, FOC014, FOC091, F0C124,
F0C160, F0D035, F0D068, F0E048, F0E082, F0E114,
FOE147, F0H075, F0H104, F0H304, F0J011, F0J053,
F0J099, F0K100, F0K117, F0K164, F0L080, F0L120,
F0L155, F0N052, F0N084, F0N124, F0N160
9. F0H061, F0J168, F0A128
10. F9P231, F9S010, F0B007, F0C015, F0C125, F0D069
F0E009, F0E049, F0H076, F0H123, F0H293, F0H119,
F0L099, F0N102, F0N179
11. F9N136, F9P296, F9S265, F0A050, F0B056, F0C091,
F0C126, F0D007, F0D036, F0E010, F0E050, F0E115,
F0H105, F0H305, F0H012, F0H054, F0H100, F0L121,
F0L170, F0N069, F0N103, F0N145, F0N180, F0N025, F0E083
12. F0J081
13. F9S285, F0E132, F0H134, F0K191, F0N110
14. F9N115, F9P238, F9S012, F9S225, F9S268, F0A064,
F0A110, F0A153, F0A186, F0B015, F0B113, F0E052,
F0H057, F0H123, F0K039, F0K140, F0L063, F0L140,
F0P026, F0J035
15. F0J269, F0A233
16. F9P305, F0A205, F0K049, F0K145, F0P032
17. F9P229, F9P287, F9S013, F9S226, F0A053, F0A111,
F0A187, F0A333, F0A334, F0B027, F0B099, F0B382,
F0C017, F0C129, F0D038, F0E053, F0H042, F0J014,
F0J057, F0K022, F0K071, F0K120, F0L051, F0L123,
F0N127, F0P012
18. F0B061, F0C177, F0H036, F0K090, F0N104, F0E028
19. F0C037, F0H095, F0K050, F0K102, F0N147
20. F0A167, F0S019, F0E027, F0K051, F0L067
21. F9P189, F0A283, F0B219, F0C066, F0D191, F0E360,
F0H212, F0H223, F0K291, F0L376, F0N249
22. F0E018, F03062, F0E092, F0E125, F0E158, F0H018,
F0H050, F0H086, FOH116, F0H316, F0H317, F0J397,
F0J418, F0K030, F0K129, F0N135, F0N169, F0P021,
FOD232, F0E420, F0H319, F0K007, F0K095, FON420
-11-
23. F0D080, F0E019, F0E126, F0H051, F0H166, F0K008,
F0K096, F0K142, F0K189, F0N182
24. F0E290, F0H215, F0H225, F0H312, F0K443, F0L362,
F0N237
25. F0H029, F0K056, F0K150, F0N149
26. F0E029, F0E134, F0H059
27. F0K009, F0K057, F0K104, F0K151, F0N062, F0N094,
F0N136, F0N170
28. F0E071, F0H030
29. F0K058, F0K105, F0K152
30. F9N145, F9P020, F9S027, F0A045, F0A120, F0A163,
F0B048, F0B088, F0B128, F0C028, F0C105, F0C141,
F0C173, F0C013, F0C046, F0F081, F0E063, F0E093,
F0E127, F0E159, F0H052, F0H087, F0H117, F0J025,
F0H068, F0J113, F0J154, F0K031, F0K081, F0K130,
F0K178, F0L059, F0L094, F0N063, F0N064, F0N095,
F0N137, F0N171, F0L134, F0L166
31. F9P021, F9P242, F9P243, F9P334, F9S029, F0A046
F0A121, F0A164, F0A199, F0B024, F0B049, F0B089,
F0B129, F0C106, F0C174, F0D082, F0E020, F0E064,
F0E094, F0E160, F0H019, F0H088, F0H118, F0J026,
F0H069, F0J114, F0J155, F0K032, F0K082, F0K131,
F0K179, F0L095, F0L167, F0L384, F0N096, F0N138,
F0N172, F0P022, F0P094
32. F9P022, F0B090, F0C107, F0C175, F0D047, F0D014,
F0E095, F0H053, F0H302, F0J129, F0K190, F0L065,
F0N185
33. F9N146, F9P023, F9P047, F0A122, F0A200, F0B050,
F0C030, F0C108, F0C142, F0C048, F0E021, F0E096,
F0E161, F0H054, F0H089, F0H119, F0J070, F0J115,
F0H156, F0K033, F0K132, F0K180, F0L096, F0L135,
F0L168, F0N097, F0N173, F0P095
34. F0A201, F0B240, F0B241, F0B296, F0C061, F0C201,
F0C235, F0C279, F0C313, F0E345, F0K450, F0K451,
F0L346, F0N326, F0N383
35. F9P261, F0C070, F0E205, F0H315, F0N419
36. F0H323.
Manufacturer: McGaw of Puerto Rico, Inc., Sabana Grande,
Puerto Rico.
Recalled by: McGaw, Inc., Irvine, California, by letter February 13,
1991. Firm-initiated recall ongoing.
Distribution: Nationwide and Canada.
Quantity: 7,221,335 units were distributed.
Reason: Product uses a piggyback feature in which the rubber
check back valve may become tilted, allowing back flow
during a secondary (piggyback) infusion.
----
-12-
Class III -
Product: CBC-7 High Hematology Control in CBC-7 Dual Pack and
Tri-Level Pack of Whole Blood Hematology Controls for
in-vitro diagnostic use. Recall #Z-651-1.
Code: Lot #R110H EXP 2/5/91.
Manufacturer: R & D Systems, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by letter October 19, 1990 and by
FAX October 23, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, France, Canada, Australia, New Zealand,
Ireland.
Quantity: 2,713 vials of CBC-7 High Hematology Control in about
600 packages of Dual Pack and Tri-Level controls
were distributed.
Reason: The product labeling for assay values and expected ranges
gave an incorrect hemogologin concentration assay
value/range.
----
VETERINARY PRODUCTS
NONE
Seizure Actions Filed:
Product: U.S.P Oxygen (90-575-171/173).
Charge: Current good manufacturing practice deficiencies.
Firm: Price-Bass Company, Inc., Nashville, Tennessee.
Filed: February 1, 1991 - U.S. District Court for the Middle
District of Tennessee; Civil #3-91-0086, FDC #66011/66013.