AUGUST 1999

WEEK ENDING AUGUST 6

PRODUCT Atenolol Tablets, USP, 25 mg, in unit dose packages of 100 (10 strips/10 tablets) and Robot Ready Cards (25 cards of 1 tablet), Rx oral beta-selective beta-adrenergic receptor blocking used in the management of hypertension and angina pectoris. NDC #51079- 759-20 and NDC #517079-759-19.
CODE Lot Numbers: 9B254, 9A124, 8M577, 8P694.
MANUFACTURER Lederle Pharmaceutical, Division of American Cyanamid, Pearl River, New York.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois
DISTRIBUTION Nationwide.
QUANTITY 27,394 unit cartons of 100 tablets and 1,582 unit cartons of 25 tablets were distributed; firm estimated that 20 percent of the products remained on market at time of recall initiation.
REASON Content uniformity failure.

PRODUCT Compressed Oxygen, USP, in H size cylinders.
CODE Lot #266-0539-64/010-6457.
MANUFACTURER Air Products & Chemicals, Inc., Guayanilla, Puerto Rico.
DISTRIBUTION Puerto Rico.
QUANTITY 22 cylinders were distributed.
REASON Current good manufacturing practice deviation - Lack of records documenting testing for potency/purity.

PRODUCT Requip® Tablets (Ropinirole HCl), 5 mg, in 100 tablet bottles, Rx taken orally for the treatment of Parkinson's disease. NDC #0007-4894-20.
CODE Lot Numbers: 680930 EXP 4/30/99, 680940 EXP 7/31/99, 720510 EXP 11/30/99.
MANUFACTURER SmithKline Beecham Pharmaceuticals, Crawlely, West Sussex.
RECALLED BY SmithKline Beecham Pharmaceuticals, Philadelphia, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY Approximately 14,033 bottles remained on market at time of recall initiation.
REASON Tablet fading: Pale blue to white.

PRODUCT Yodoxin 650 mg Tablets (lodoquinol USP), in 100 tablet bottles, Rx anti-amebic. NDC #0516-0093-01.
CODE Lot #49835 EXP 9/2001.
MANUFACTURER Glenwood, LLC, Piscataway, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY 976 bottles were distributed.
REASON Subpotency (6 month stability).

PRODUCT Protect U-2000 Aerosol, (Pyrethrins Extract 0.30, Piperonyl Butoxide Technical 3.00, Inert Ingred 96.70), in 5 oz cans, OTC aerosol used for the control of body lice, head lice, crabs, nits, and chiggers on human ind inanimate surfaces.
CODE All lot codes.
MANUFACTURER DiHoMa Chemical and Manufacturing, Inc., Mullins, South Carolina.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 14,014 cans were distributed; firm estimated that 700-800 cans remained on market at time of recall initiation.
REASON Product is an unapproved new drug.

PRODUCT Quick Pep® Alertness Aid Tablets, 150 mg caffeine anhydrous, USP, 32 tablet units, OTC indicated as a stimulant. NDC #11926-006-32.
CODE Lot Numbers: SQP196A and SQP796A.
MANUFACTURER Sidmak Laboratories, E. Hanover, New Jersey.
RECALLED BY Thompson Medical Company, Inc., Fairfield, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 59,940 cartons were distributed.
REASON Mislabeling - blister card incorrectly declares caffeine anhydrous, USP, Strength as 200 mg (outer holding cartoncorrectly labeled as 150 mg).

PRODUCT Procainamide Hydrochloride Extended Release Tablets, Rx products indicated for use as an anti-arrhythmic:
a) Procanbid(tm) Tablets Extended-Release , 500 mg, in 60 tablet bottles; b) Procanbid(tm) Tablets, Extended-Release, 1000 mg, in 60 tablet bottles.
CODE a) Lot #795D6D EXP 10/99, N0071-0562-20 Lot #797D6D EXP 10/99, N0071-0562-20;
b) Lot #33137D EXP 02/00, N0071-0564-20.
MANUFACTURER Warner-Lambert Company, Morris Plains, New Jersey.
RECALLED BY The Parke-Davis Division of Warner-Lambert Company, Morris Plains, New Jersey
DISTRIBUTION Nationwide.
QUANTITY a) 44,098 bottles; b) 10,592 bottles were distributed; firm estimated that minimal amount of product remained on market at time of recall initiation.
REASON Dissolution failure.
 

WEEK ENDING AUGUST 20

PRODUCT Aminohippurate Sodium Injection, 2g in 10 mL (20% Solution) in 10 mL single dose vials, Rx used for the treatment of effective renal plasma flow,(ERPF). NDC #0006-339511.
CODES Lot numbers: 0703B EXP May 00, 1498B EXP May 00, 0334D EXP Nov 00, 0839D EXP Nov 00, 0178J EXP Nov 00, 1075D EXP Jan 01, 1289D EXP Jan 01, 0035E EXP Jun 01, 0035ESA1 EXP Jun 01, 0956E EXP May 02, 1546E EXP May 02, 0476H EXP Mar 03, 1111H EXP Mar 03, 1722H EXP Jun 03.
MANUFACTURER Merck and Company, West Point, Pennsylvania.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that 300 units remained at the wholesale level at time of recall initiation.
REASON Glass particulate contamination.

PRODUCT Erythromycin Ophthalmic Ointment, USP, 0.5%, Rx, in 3.5 g tubes.
CODE Lot #065151 EXP 5/00.
MANUFACTURER Bausch & Lomb Pharmaceuticals, Inc., Tampa, Florida.
DISTRIBUTION Nationwide.
QUANTITY 49,968 units were distributed.
REASON Product mix-up - Correctly labeled Muro 128Æ Ointment tube (sodium chloride 5%) found in carton of erythromycin product.

PRODUCT Lonox Tablets (Diphenoxylate HCL, USP 2.5mg / Atropine Sulfate, USP 0.025mg) in 100 and 1,000 tablet bottles, Rx combination ingredient tablet for the management of diarrhea. NDC# 0781-1262- 01 (100's) and 0781-1262-10 (1000's).
CODE Lot #10057 EXP 09/01.
MANUFACTURER Geneva Pharmaceuticals, Inc., Broomfield, Colorado.
DISTRIBUTION Nationwide.
QUANTITY 5,880,500 tablets were distributed.
REASON Subpotency.

PRODUCT a) Apetonil Jarabe Para Adultos, (Cyproheptadine HCL 2.5mg/5ml) in 120 mL bottles (Appetite Stimulate Syrup for Adults); b) Apetonil Jarabe Infantil, (Cyproheptadine HCL 1.5mg/5ml) in 120 mL bottles (Appetite Stimulate Syrup for children/infants).
CODE All lot codes.
MANUFACTURER Laboratorio MAGNECHEM International, S.A., Zone Industrial de Haina, Republica Dominicana.
RECALLED BY Castillo Distributors, Inc., Little Ferry, New Jersey
DISTRIBUTION New York.
QUANTITY 3,470 120mL-bottles (Total of 2,622 bottles of Apetonil Jarabe Infantil, and 846 bottles of Apetonil Jarabe Para Adultos) were distributed.
REASON Products are unapproved new drugs and are misbranded (Rx product sold as OTC).

PRODUCT Generic inhalatin solutions sold as Rx drugs under the DEY label:
a) Albuterol Sulfate Inhalation Solution, 0.083%, in 3 mL vials, Sterile, Unit Dose, indicated for the relief of bronchospasm in patients 2 years and older with reversible obstructive airway disease and acute attacks of bronchospasm. NDC 49502-697-03 = 25 vials/carton
NDC 49502-697-33 = 30 vials/carton
NDC 49502-697-60 = 60 vials/carton;
b) Ipratropium Bromide Inhalation Solution, 0.02%, in 2.5 mL vials, Sterile, Unit Dose, indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
NDC 49502-685-03 = 25 vials/carton,
NDC 49502-685-33 = 30 vials/carton
NDC 49502-685-60 = 60 vials/carton. Recall #D-307/308-9.
CODE a) 227 multiple lots with EXP dates ranging from 08/99 to 02/01; b) 223 multiple lots with EXP dates ranging from 01/00 to 09/00.
MANUFACTURER Dey, LP, Napa, California.
DISTRIBUTION Nationwide.
QUANTITY Approximately 110 million vials of Albuterol Sulfate Solution and 84 million vials of Ipratropium Bromide Inhalation Solution were distributed.
REASON Contamination - Impurity from packaging material (1-Phenoxy-2 Propranol).

PRODUCT Riopan Plus Suspension, OTC buffer antacid plus anti-gas combination:
a) Riopan Plus Suspension, Antacid & Anti-Gas, in 12 fluid ounce bottles. NDC #0573-3210-20;
b) Riopan Plus; Double Strength Suspension Antacid & Anti-Gas, in 12 fluid ounce bottles. NDC #0573-3220-20.
CODE The following represent all lots currently on the market:
(a) 3971121 EXP 7/99 3971879EXP 8/99
3971960 EXP 9/99 3972064 EXP 11/99
3981108 EXP 1/00 3981542 EXP 1/00
3981330 EXP 3/00 3981358 EXP 4/00
3981670 EXP 6/00 3981596 EXP 7/00
3982317 EXP 8/00 3982318 EXP 9/00
3981746 EXP 9/00 3982341 EXP 10/01
(b) 3971123 EXP 7/99 3971124 EXP 8/99
3971961 EXP 10/99 3971880 EXP 10/99
3971965 EXP 12/99 3981109 EXP 1/00
3981465 EXP 1/00 3981331 EXP 2/00
3981673 EXP 2/00 3981574 EXP 3/00
3981349 EXP 4/00 3982023 EXP 5/00
3982024 EXP 5/00 3982134 EXP 6/00
3981376 EXP 6/00 3981598 EXP 7/00
3982319 EXP 8/00 3982320 EXP 8/00
3982321 EXP 9/00 3981747 EXP 9/00
3982322 EXP 10/01.
MANUFACTURER Wyeth-Ayerst Laboratories, Rouses Point, New York.
RECALLED BY Whitehall-Robins Healthcare, Richmond, Virginia
DISTRIBUTION Nationwide.
QUANTITY 1,421,000 bottles have been distributed between August 1997 and June 1999.
REASON Mislabeling - Label declares preservatives not in product- Methylparaben, Propylparaben, Citric Acid, and Benzyl Alcohol.

PRODUCT Losopan Antacid (Magaldrate Oral Suspension Antacid 540 mg/5mL, in 12 fluid ounce bottles, OTC indicated for the relief of heartburn, sour stomach and/or acid indigestion and upset stomach associated with these symptoms. NDC #0182-6078-39.
CODE Lot #81235 EXP 12/00.
MANUFACTURER RIJ Pharmaceutical Corporation, Middletown, New York.
DISTRIBUTION Kentucky.
QUANTITY 5,208 bottles were distributed.
REASON Mislabeling - Some bottles bear an incorrect antacid back label (Goldline Genaton(tm)).

PRODUCT Indapamide 2.5 mg Tablets, in 100 and 1,000 tablet bottles, oral diuretic indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. It is also indicated for the treatment of salt and fluid retention associated with congestive heart failure. This product is labeled under the firm's generic name Arcola. NDC 0070-3000-00 for the 100 count bottles and NDC 0070-3000-99 for the 1000 count bottles.
CODE Lot #MN3386 EXP 11/02 (bottles of 100); Lot #MN3396 EXP 11/02 (bottles of 1000).
MANUFACTURER Rhone Poulenc Rorer Puerto Rico, Inc., Manati, Puerto Rico.
RECALLED BY Rhone Poulenc Rorer Pharmaceuticals, Collegeville, Pennsylvania
DISTRIBUTION Nationwide and the Caribbean.
QUANTITY 32,106 bottles of Lot MN3386 and 35,986 bottles of Lot MN3396 were distributed nationwide. 3,024 bottles of Lot MN3386 were sent to RPR Caribbean; firm estimates that very little of the two lots are left in commercial channels.
REASON Dissolution failure.
 

WEEK ENDING AUGUST 27

PRODUCT Naproxen Tablets, USP, 500 mg, Rx in 500 tablet bottles. NDC #0781-1165-05 (Naprosyn),.
CODE Lot #105820 EXP 04/2002.
MANUFACTURER Geneva Pharmaceuticals, Inc., Broomfield, Colorado.
DISTRIBUTION Nationwide.
QUANTITY 3,440 bottles were distributed.
REASON Metal wire/particle contamination.

PRODUCT
1. AntiliriumÆ Injection (Physostigmine salicylate), 1 mg/mL, 2 mL ampules, under the Forest label
2. Artificial Tears Plus - Lubricant, Ophthalmic Solution, (Polyvinyl Alcohol 1.4%) 15 mL bottle, under the following labels: Steris, Rugby, Schein, Canada
3. Artificial Tears- Lubricant, Ophthalmic Solution, (Polyvinyl Alcohol 1.4%) 15 and 30 mL bottles, under the following labels: Steris, Scein, AARP Pharmacy Service
4. Ascorbic Acid Injection, (Preserved) 222 mg/mL, 30 mL Multiple Dose Vial, under the following labels: Steris, Schein, McGuff, Merit
5. Atropine Sulfate Opthalmic Solution, USP, 1%, 15 mL bottle, under the following labels: Steris, Schein, The Butler Company
6. Vitamin B Complex 100 Injection (Thiamine Hydrochloride 100 mg), 30 mL multiple dose vials, under the following labels: Steris, Merit, McGuff, Darby Group, Hyrex, Key Company
7. Betamethasone Sodium Phosphate Injection, USP 4 mg/mL (equiv. to Betamethasone 3 mg/mL), 5 mL vials, under the following labels: Steris, Schein, Darby UAD Laboratories
8. Brompheniramine Maleate Injection, USP, 10 mg/mL, 10 mL Multiple Dose Vials, under the following labels: Steris, Schein, Forest, Hyrex, Clint
9. Chlorpheniramine Maleate Injection, USP, 10 mg/mL, 10 mL Multiple Dose Vials, under the Steris label
10. Cyanocobalamin Injection, USP, 100 mcg/mL, 30 mL Multiple Dose Vials, under the following labels Steris, Moore, Rugby, Goldline
11. Cyanocobalamin Injection, USP, 1000 mcg/mL, 10 and 30 mL Multiple Dose Vials, under the following labels: Steris, Schein, Moore, Rugby, Goldline, Carlisle, International Ethical Lab, Major, URL, IDE Interstate, Generics of Puerto Rico, Keene, Darby, Sorter Laboratories, Clint, Cytex, Schein Canada, Taro, Key Company, McGuff, Merz, San Jose Surgical, Martin Surgical, Besse, Forest, Wesley, Merit, Robar, CO Truxton, Legere, Stewart Jackson
12. Dalalone D.P.Æ (Dexamethasone Acetate Injectable Suspension, USP), 16 mg/mL, 1 and 5 mL vials, under the Forest label
13. Dalalone D.P.Æ (Dexamethasone Acetate Injectable Suspension, USP), 8 mg/mL, 5 mL vials, under the following labels: Steris, Schein, Moore, Rugby, Goldline, Major, URL, AF Hauser, Keene, Darby, Clint, Insource, Allied Pharmaceutical Group, Merz Pharmaceuticals, San Jose Surgical, Martin Surgical Supply, Besse Medical, Forest, Teregen Labs, Radford Therapeutics, Robar, Legere Pharmaceuticals, Stewart Jackson
14. Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 5 mL Multiple Dose Vials, under the following labels: Steris, Schein, Moore, Rugby, Goldline, URL, Ace Surgical Supply, Clint, RW Enterprise, Merz Pharmaceuticals, Forest Pharmaceuticals, Teregen Labs, Legere, Cytex, Taro
15. Dexamethasone Sodium Phosphate Injection, USP, 10 mg/mL, 10 mL Multiple Dose Vials, under the following labels: Steris, Schein, Clint, Robar
16. Dexamethasone Sodium Phosphate (Ophthalmic Solution, USP), 0.1% , 5 mL Squeeze Dropper Bottle, under the following labels: Steris, Schein, Moore, Rugby, URL, Butler, Darby, Akorn, E Fougera, Pharmascience, Dioptic Laboratories
17. Dexpanthenol Injection, 250 mg/mL, 30 mL Multiple Dose Vial, under the following labels: Steris, McGuff, Merit
18. Diazepam Injection, USP, 5 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Moore, Darby, Goldline, URL, Ace Surgical Supply, Western Medical Supply
19. Dicyclomine Hydrochloride Injection, USP, 10 mg/ml, 10 mL Multiple Dose Vial, under the Schein label
20. Dicyclomine Hydrochloride Injection, USP, 20 mg / 2mL, 2 mL vial, under the Steris and Schein labels
21. Dimenhydrinate Injection, USP, 50 mg/mL, 1 and 10 mL vials, under the Steris and Schein labels
22. Diphenhydramine HCL Injection, USP, 50 mg/mL, 10 mL Multiple Dose Vials, under the following labels: Steris, Schein, Moore, Goldline, Schein Canada, Pharmascience
23. Diphenhydramine HCL Injection, USP, 10 mg/mL, 30 mL Multiple Dose Vials, under the Steris, Schein, Darby labels
24. Dobutamine Injection, USP, 250 mg/20mL, 20 mL Single Dose Vial, under the Schein label
25. Doxapram Hydrochloride Injection, USP, 20 mg/mL, 20 mL Multiple Dose Vials, under the Steris and Schein labels
26. Estradiol Cypionate Injection, USP, 5 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Darby, Goldline, Forest, Clint
27. Estradiol Valerate Injection, USP, 20 mg/mL, 10 mL Multiple Dose Vial, under the Steris, Schein, Flint labels

  1. Estradiol Valerate Injection, USP, 40 mg/mL, 10 mL Multiple Dose Vial, under the Steris, Schein, Clint labels
  2. Gentamicin Sulfate, Ophthalmic Solution, USP, 0.3%, 5 mL Squeeze Dropper Bottle, under the following labels: Steris, Schein, Darby, Moore, E Fougera, Schein Canada, Technilab
  3. Garatec-Gentamicin Sulfate OTIC Drops, 0.3%, 5 mL Bottle, under the Technilab label
  4. Heparin Sodium Injection, USP, 5,000 Units/mL, 10 mL Multiple Dose Vial, under the Steris, Schein, URL labels
  5. Heparin Sodium Injection, USP, 10,000 Units/mL, 10 mL Multiple Dose Vial, Under the Steris, Schein, Rugby labels
  6. Hydrocortisone Acetate Suspension, USP, (for injection), 25 mg/mL, 10 mL vial, under the Steris, Schein, URL, Darby labels
  7. Hydromorphone HCL Injection, USP, 10 mg/mL, 1 mL ampul, under the Marsam Pharmaceutical label
35. Hydromorphone HCL Injection, USP, 50 mg/5mL, 5 mL ampul, under the Marsam Pharmaceutical label
36. Hydroxyprogesterone Caproate Injection, USP, 250 mg/mL, 5 mL Multiple dose vial, under the following labels: Steris, Schein, Rugby, Hyrex, Wintec
37. Hydroxyzine Hydrochloride Injection, USP, 25 mg/mL, 10mL Multiple Dose Vial, under the Steris and Schein labels
38. Hydroxyzine Hydrochloride Injection, USP, 50 mg/mL, 10mL Multiple Dose Vial, under the following labels: Steris, Schein, Moore, Rugby, Goldline, Darby, Clint
39. Levothyroxine Sodium for Injection, lyophilized, 200 mcg/vial, single dose vial, under the Schein label
40. Levothyroxine Sodium for Injection, lyophilized, 500 mcg/vial, single dose vial, under the Steris and Schein labels
41. Lidocaine Hydrochloride Injection, USP, 1%, 50 mL, Multiple Dose Vial, under the following labels: Steris, Schein, Moore, Rugby, Goldline, Darby, Clint, Forest, Teregen Labs, URL
42. Lidocaine Hydrochloride Injection, USP, 2%, 50 mL, Multiple Dose Vial, Steris, Schein, Moore, Goldline, Darby, Clint, Forest, Teregen
43. Lincomycin Hydrochloride Injection, USP, 300 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Moore, Goldline, Darby, Clint, Llorens, Keene, Besse, Radford Therapeutics, Martin Surgical Supply
44. Lorazepam Injection, USP, 2 mg/mL, 1 and 10 mL vials, under the Marsam label
45. Lorazepam Injection, USP, 4mg/mL, 10 mL vial, under the Marsam label
46. Meperidine Hydrochloride Injection, USP, 300 mg/30mL, 30 mL Single Dose Vial, under the Schein label
47. Meperidine Hydrochloride Injection, USP, 50 mg/mL, 30 mL Multiple Dose Vial, under the Steris and Schein labels
48. Meperidine Hydrochloride Injection, USP, 100 mg/mL, 20 mL Multiple Dose Vial, under the Steris and Schein labels
49. Mepivacaine Hydrochloride Injection, USP, 1%, (10 mg/mL), 50 mL Multiple Dose Vial, under the Steris and Schein labels
50. Mepivacaine Hydrochloride Injection, USP, 2%, (20 mg/mL), 50 mL Multiple Dose Vial, under the Steris and Schein labels
51. Methylprednisolone Acetate Injection Suspension, USP, 20 mg/mL, 10 mL Multiple Dose Vial, under the Steris and Radford labels
52. Methylprednisolone Acetate Injection Suspension, USP, 40 mg/mL, 5 and 10 mL Multiple Dose Vial, Steris, Schein, Moore, Goldline, URL, Clint, San Jose Surgical, Besse, Forest, A&G Pharmaceuticals, Radford Therapeutics, Merz Pharmaceutical, Stewart Jackson Pharmaceutical, Darby Group
53. Methylprednisolone Acetate Injection Suspension, USP, 80 mg/mL, 5 mL Multiple Dose Vial, under the following labels: Steris, Schein, Moore, Rugby, Goldline, URL, Hyrex, Keene, Clint, Merz, San Jose Surgical, Besse, Forest, Radford, Legere, Stewart Jackson
54. Methocarbamol Injection, USP, 100 mg/mL, 10 mL Single Dose Vial, under the following labels: Steris, Schein, Univet Pharm, Pharmascience, Brock Vet Supply
55. Morphine Sulfate Injection, USP, 15 mg/mL, 20 mL Multiple Dose Vial, under the Steris and Schein labels
56. Neomycin and Polymyxin B Sulfates and Hydrocortisone, OTIC Solution, USP, 10 mL Sterile bottle with Sterilized Dropper, under the following labels: Steris, Schein, Moore, Parmed, Darby, Teva, E Fougera, Robar, Generics of Puerto Rico, Teral Labs, Erva Pharmaceuticals, Pedinol Pharmaceutical, Akorn, Marlop, URL
57. Neomycin and Polymyxin B Sulfates and Hydrocortisone, OTIC Suspension, USP, 10 mL Sterile bottle with Sterilized Dropper, under the following labels: Steris, Schein, Moore, Rugby, Goldline, UAD Labs, E Fougera, Generics of Puerto Rico, Teral Labs, URL, Akorn
58. Neomycin and Polymyxin B Sulfates Solution For Irrigation, USP, 20 mL Multiple Dose Vial, under the Schein label
59. Neomycin Sulfate and Desamethasone Sodium Phosphate, Ophthalmic Solution, USP, 5 mL Squeeze Dropper Bottle, under the Steris, Schein, E Fougera labels
60. Neostigmine Methylsulfate Injection, USP, 1:2000 (0.5 mg/mL-500 micrograms/mL), 10 mL Multiple Dose Vials, under the Steris and Schein labels
61. Orphenadrine Citrate Injection, USP, 60 mg/2 mL, in 2 mL Ampul, under the following labels: Steris, Schein, International Ethical Lab, Cytex
62. Orphenadrine Citrate Injection, USP, 30 mg/mL, in 10 mL vial, under the following labels: Steris, Schein, Deliz, Clint, Forest
63. Phenylephrine Hydrochloride Injection, USP, 1% (10 mg/mL) 1 mL vial, Single Dose, under the Schein label
64. Pilocarpine Hydrochloride Ophthalmic Solution, USP, 1%, 15 mL Sterile Squeeze Bottle, under the following labels: Steris, Schein, Butler, Schein Canada, Technilab
65. Pilocarpine Hydrochloride Ophthalmic Solution, USP, 2%, 15 mL Sterile Squeeze Bottle, under the following labels: Steris, Butler, Schein Canada, Technilab, Dioptic
66. Pilocarpine Hydrochloride Ophthalmic Solution, USP, 4%, 15 mL Sterile Squeeze Bottle, under the Steris, Schein, Technilab labels
67. Prednisolone Acetate Suspension, USP (Sterile), for intramuscular and intra-articular injection, 25 mg/mL, 30 mL Multiple Dose Vial, under the Steris Schein, and Forest labels
68. Prednisolone Acetate Injectable Suspension, USP (Sterile), for intramuscular and intra-articular injection, 50 mg/mL, 10 and 30 mL Multiple Dose Vial, under the following labels: Steris, Schein, Forest, Darby, Goldline
69. Prednisolone Sodium Phosphate Ophthalmic Solution, USP, 1/8%, 5 mL Squeeze Dropper Bottle, under the Steris, Schein, and Akorn labels
70. Prednisolone Sodium Phosphate Ophthalmic Solution, USP, 1%, 5, 10 & 15 mL Squeeze Dropper Bottles, under the following labels: Steris, Schein, Akorn, E Fougera, Butler
71. Prochlorperazine Edisylate Injection, USP, 5 mg/mL, 10 mL Multiple Dose Vial, under the Steris and Schein labels
72. Progesterone Injection, USP, 50 mg/mL, 10 mL Sterile Multiple Dose Vial, under the following labels: Steris, Schein, Moore Rugby, Goldline, Paddock, Eveready, URL, Cytex, Germiphene
73. Pyridoxine Hydrochloride Injection, USP, 100 mg/mL, 10 and 30 mL Multiple Dose Vial, Steris, Schein, McGuff, Merit, Key Company, Legere, Kripps Pharmacy
74. Pentamidine Isethionate for Injection, 300 mg, Lyophilized, Single Dose Vial, under the following labels: Marsam, Pasadena Research Labs
75. Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution, 10% / 0.25%, 5 and 10 mL Squeeze Dropper Bottle, under the following labels: Steris, Schein, E Fougera
76. Sulfacetamide Sodium Ophthalmic Solution, USP, 10 %, 15mL Squeeze Dropper Bottle, under the Forest label
77. SUS-PHRINEÆ (epinephrine 5 mg/mL ) Injectable Suspension, 1:200 , 0.3 mL/Sterile ampul and 5 mL Multiple Dose Vial, under the Forest label
78. Testosterone Cypionate-Estradiol Injection, 50 mg/2mg/mL, 10 mL Multiple Dose Vial, under the Steris, Schein, and Forest labels
79. Testosterone Cypionate Injection, USP, 100 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Goldline, Schein Canada, Cytex
80. Testosterone Cypionate Injection, USP, 200 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Darby, Rugby, Goldline, Star, URL
81. Testosterone Enanthate-Estradiol Valerate Injection, 90 mg/ 4 mg per mL, 10 mL Sterile Multiple Dose Vial, under the Steris and A&G Pharm labels
82. Testosterone Enanthate Injection, USP, 200 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Rugby, Forest, Darby, URL, Pharmascience, Taro
83. Testosterone Injection, USP, 100 mg/mL, 30 mL Multiple Dose Vial, under the following labels: Steris, Schein, Univet, Vetoquinol Canada, Brock Veterinary Supply
84. Testosterone Propionate Injection, USP, 100 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Goldline, URL, Cytex, Taro, Germiphene
85. Thiamine Hydrochloride Injection, USP, 100 mg/mL, 30 mL Sterile Multiple Dose Vial, under the Steris, McGuff and Merit labels
86. Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL, Squeeze Dropper Bottle, under the Steris, Schein, and E Fougera labels
87. TacÆ-3 Injectable Suspension (Triamcinolone Acetonide) 3 mg/mL, 5 mL Multi-dose vial, under the Parnell and Allergan labels
88. Triamcinolone Acetonide Injectable Suspension, USP, 40 mg/mL, 1 and 5 mL vials, under the following labels: Steris, Schein, Goldline, RW Enterprise, Schein Canada, Moore, Rugby, URL, Major, Teregen, Clint, Besse, San Jose Surgical, Robar, Forest, Darby, Legere, AF Hauser, CO Truxton, Merz, Cytex
89. Triamcinolone Diacetate Injectable Suspension, USP, 40 mg/mL, 5 mL Multiple Dose vials, under the following labels: Steris, Schein, Moore, Rugby, Goldline, URL, Keene, Carlisle, Clint, Besse, San Jose Surgical, Darby, Forest, Quality Research Pharmaceuticals, Stewart Jackson Pharmaceutical, Hyrex, CO  Truxton, Wintec, Mayrand, Taro Legere, Merz, Forest
90. Trifluridine Ophthalmic Solution, 1%, 7.5 mL Squeeze Dropper Bottle, under the Schein label
91. Trimethobenzamide Hydrochloride Injection, USP, 100 mg/mL, 20 mL vial, under the Steris and Schein labels
92. Heparin Sodium Injection, USP, 20,000 Units/mL, 5 mL Multiple Dose vial, under the Steris, Schein, and Rugby labels
93. Nandrolone Decanoate Injection, USP, 50 mg/mL, 2 mL Multiple Dose Vials, under the Steris and Schein labels.
CODE Lot numbers:
1. 96N690, 97F720, 97M430, 98C350
2. 97D180, 97G520, 97J831, 97M300
3. 97A070, 97A730, 97B370, 97B650, 97B660, 97B870, 97C040, 97C681, 97C820, 97D200, 97D300, 97D340, 97D421, 97D430, 97B650, 97B660
4. 96F150, 96L590, 97B290, 97D090, 97J900, 98B800, 98E290
5. 97A520, 97B590, 97G470, 97G680, 97G681
6. 97B890, 97C880, 97C890, 97G530, 98A700, 98A710
7. 97B700
8. 97F080, 97L020
9. 96G970
10. 96F910
11. 96C240, 96F800, 96H640, 96J470, 96N760, 96A080, 97D050, 97D630, 97K240, 97K241, 97M240, 97M241, 96C410, 96E410, 96F160, 96H240, 96H410, 96J070, 96K920, 96L780, 96L940, 96N380, 96N381, 97A060, 97B720, 97C800, 97D220, 97D690, 97F820, 97G310, 97J580, 98A691
12. 97B740, 98C631 ,96B720, 96D110, 96F351, 96L681, 97B741, 97F090, 97M100, 98C630
13. 97A420, 97A930, 97C130, 97C690, 97E190, 97K610, 97L010, 97L140, 97L970, 98A280, 98A890, 98B930
14. 97G281, 97L161, 98E021
15. 97G510
16. 97A260, 97B940, 97H850, 97D280, 97F490, 97F741, 97G750, 97J220, 97J221, 97K930, 97M380, 98A790
17. 97B840, 97M220, 98A180
18. 97B100, 97C910, 97D460, 97D461, 97E130, 97F300, 97H940, 97L310, 98A220, 98A221, 98A900, 98A901, 98B950
19. 97F060 and 97J270
20. 97A160, 97C720, 97G721, 97H890, 97H891, 98A050
21. 97D450, 97H310, 98A020, 98E270, 98E271, 97B970, 97F140
22. 97A660, 97B020, 97B540, 97C180, 97F310, 97F330, 97F331, 97J160, 97K100, 97K320, 97K620, 97L380, 98B320, 98D780
23. 97C140 and 97J310
24. 97C400 and 98C810
25. 98A510 and 97C120
26. 96E840, 96G980, 97C230, 97F410, 97L930, 98B200
27. 96J250, 97F101, 97J420
28. 96B410, 96J370, 97M060
29. 97A900, 97A901, 97B310, 97D680, 97E120, 97G440, 97C850
30. 97C850
31. 97E390
32. 97F320 and 97G500
33. 96C120, 96L430, 96N540, 98A210, 98D430
34. 97D790 and 98A090
35. 97A680, 97B130, 97B140, 97C990, 97J170
36. 97M180, 97H370, 96C090
37. 96G920 and 97D410
38. 96E740 and 97B900
39. 96C310, 96C970, 96D910, 96L050, 96L100, 97B640, 97C630
40. 96J050 and 97C360
41. 96A560, 96A980, 96C080, 96C530, 96D050, 96E150, 96G730, 96K270, 96L420, 97B350, 97C840, 97F940
42. 97F130, 97A410, 96B370, 96D180, 96E160, 96J880, 97B610
43. 97A430, 97A690, 97A860, 97C830, 97F460, 97G770, 97J230, 97J550, 97M230, 98C810
44. 97B730, 97C450,97B731
45. 97A380
46. 97A170, 97C050, 97C240, 97D590, 97E210, 97F250, 97F260, 97J950, 97J960, 98B130, 98C010
47. 97G190 and 97J630
48. 97A190
49. 97D970, 97G130, 97H960, 97M280, 98B830
50. 97B260, 97G260, 97K730, 98B870, 98B880, 98D190
51. 97L300 and 97M450
52. 97A590, 97A910, 97F200, 97F201, 97H590, 97J430, 97J540, 97L510, 97B580, 97F420, 97K420, 97K490, 97M140, 98B300
53. 97A810, 97C870, 97H930, 97H931, 97J290, 97L440, 97M030, 98B520, 98B960
54. 97F480
55. 97B9890 and 97D841
56. 96A360, 96A490, 97A090, 97A640, 97A870, 97C030, 97D710, 97D711, 97E030, 97E580, 97E581, 97E590, 97E670, 97E671, 97E920, 97E921, 97F910, 97F911, 97G160, 97G161, 97H050, 97H051, 97H430, 97H431, 97H510, 97H630, 97H631, 97J400, 97J490, 97J910, 97K150, 97K410, 97L130, 97L390, 97M370, 98B400, 98B470, 98B840, 98B910, 98B911, 98C130, 98C320, 98C510, 98C512
57. 97A500, 97A560, 97A580, 97A600, 97A610, 97A700, 97A790, 97A800, 97A960, 97A970, 97B040, 97B050, 97B750, 97B760, 97B761, 97B850, 97B860, 97B920, 97B930, 97C100, 97C110, 97C160, 97C170, 97C920, 97C930, 97D030, 97D040, 97D880, 97D891, 97D930, 97D940, 97E060, 97E070, 97E170, 97E180, 97E240, 97E250, 97E350, 97E351, 97E360, 97E630, 97E640, 97E710, 97E720, 97E730, 97E740, 97E750, 97E751, 97E760, 97E770, 97E780, 97E790, 97E800, 97E810, 97E820, 97F920, 97G030, 97G040, 97G080, 97G090, 97G360, 97G370, 97G860, 97G870, 97G930, 97H080, 97H090, 97H160, 97H410, 97H420, 97H440, 97H450, 97H470, 97H480, 97H540, 97H550, 97H650, 97H660, 97H661, 97H920, 97H921, 97J440, 97J450, 97J790, 97J800, 97J810, 97K010, 97K170, 97K180, 97K220, 97K221, 97K230, 97K300, 97K310, 97L060, 97L070, 97L170, 97L180, 97L181, 97L340, 97L350, 97L420, 97L430, 97M050, 97M150, 98A400, 98A410, 98A730, 98A740, 98A741, 98B220, 98B230, 98B430, 98B440, 98B660, 98B850, 98B851, 98B860, 98C180, 98C190, 98C401, 98C402, 98C410, 98C411, 98C480, 98C550, 98C600, 98C820, 98C821, 98D120, 98D160, 98D170, 98D220, 98D230, 98D320,
98D330, 98D400, 98D410, 98D412, 98D490, 98D491, 98D550, 98D640, 98E160, 98E200, 98E201, 98E330, 98E420
58. 96F420, 96H870, 97C330, 98A360, 98B150
59. 97A710 and 97H320
60. 96D290
61. 96G600, 96H960, 96J940, 97A950, 97D100, 97D650, 97E550, 97E600, 97J080, 97L580, 97M250, 98A290, 98A840, 98C040
62. 96A200, 96B070, 97B300, 97F900
63. 96A870, 96C280, 96D940, 96H990, 96L270, 97B080, 97B800, 97C420, 97E990, 97G760, 97G960, 97H820, 97H910
64. 97D380 and 97K500
65. 97C190
66. 97B401
67. 96D140, 96N290, 97B410, 97D230
68. 96M630, 96B670, 96E260, 96L540, 96M640, 97B490, 97C980, 97L650
69. 97M260
70. 97H330, 97L810, 98A820, 97L740, 97L610, 98A040
71. 97B060, 97B770, 97D210, 97D211, 97E440, 97E450, 97F120, 97F190, 97G850, 97L410, 98A540
72. 97D020, 97F070, 97F450, 97H060, 97H770, 97J120, 98A390, 98B710
73. 97E100, 97E101, 98D890, 97A480, 97F351, 98B280, 98B290
74. 97B520, 97K640, 97L250, 97L520, 98E800, 98A480
75. 97K360, 97K450, 97L840, 97L940, 97L950, 98A880, 97K340, 97L950, 98A960, 98B590
76. 97A980, 97B420, 97C750, 97E230
77. 97M040, 96N400. 97K480, 98B240
78. 97F360
79. 96E830, 96N630, 97K120
80. 96C050, 96F970, 96H930, 96K130, 96M050, 97C900, 97E040, 97F770, 97H530, 97K680, 97K681, 98A130
81. 97F290
82. 96A160, 96H300, 96K320, 96K510, 97E310, 97E490, 97G550, 97G900, 97L030, 98A760, 98B970, 98D390
83. 96J990, 96M040, 97F850, 97J970, 97L150, 97L600, 98B410
84. 96E062, 96K430, 97C760, 97K590, 97L980, 98C460
85. 97B480 and 97C410
86. 97C950, 97F240, 97H300, 97L050, 97L720, 98A860, 98A870
87. 96B600, 97E500, 98A770
88. 97D830, 97D831, 97F830, 97J340, 97K670, 97K160, 98A330, 98B700, 98C370, 98C720, 98D090, 97A250, 97B360, 97D800, 97D810, 97D820, 97F270, 97F831, 97G050, 97J330, 97J341, 97K161, 97K540, 97K671, 97M170, 97M410, 98A331, 98B271, 98B701, 98C200, 98C371, 98C560, 98C721, 98D091, 98D210, 98D470, 98D310
89. 96A640, 96B490, 96C360, 96C470, 96D340, 96E390, 96H050, 96J730, 96M460, 97B830, 97E080, 97F500, 97K660, 98E360, 98B490, 98B940
90. 97C300, 97F030, 97F370, 97F620, 97G340, 97H840, 98A850, 98D240
91. 96D020, 97D260
92. 96D020, 97D260
93. 97F890, 97J620.
MANUFACTURER Steris Laboratories, Phoenix, Arizona.
DISTRIBUTION Nationwide and international.
QUANTITY Number of vials or units distributed:
1) 230,412 vials; 2) 35,012 vials; 3) 389,970 15-ml bottles and 34,337 30-ml bottles; 4) 159,381 vials; 5) 66,529 bottles; 6) 131,795 vials; 7) 78,126 vials; 8) 32,374 vials; 9) 13,450 vials; 10) 29,990 vials; 11) 1,244,548 10-ml vials and 1,088,261 30-ml vials; 12) 64,210 1-ml and 363,968 5-ml vials; 13) 1,118,536 vials; 14) 97.821 vials; 15) 31,960 vials; 16) 386,874 vials; 17) 10,970 vials; 18) 713,274 vials; 19) 70,527 vials; 20) 569,200 vials; 21) 973,200 1-ml vials and 102,529 10-ml vials; 22) 336,186 vials; 23)48,926 vials; 24) 87,824 vials; 25) 13,068 vials; 26) 210,813 vials; 27) 127,826 vials; 28) 107,441 vials; 29&30) 449,494 vials; 31) 10,018 vials; 32) 17,058 vials; 33) 78,638 vials; 34) 163,090 ampuls; 35) 139,070 ampuls; 36) 96,192 vials; 37) 45,361 vials; 38) 136,607 vials; 39) 82,786 vials; 40) 28,794 vials; 41) 338,345 vials; 42) 173,074 vials; 43) 311,675 vials; 44) 65,512 (1 ml) and 4,901 (10 ml) vials; 45) 1,591 vials; 46) 98,145 vials; 47) 17,775 vials; 48) 8,643 vials; 49) 147,894 vials; 50) 111,133 vials; 51) 33,620 vials; 52) 484,679 (5 ml) and 202,836 (10 ml) vials; 53) 683,697 vials; 54) 94,269 vials; 55) 47,769 vials; 56) 2,811,407 bottles; 57) 5,730,538 bottles; 58) 48,995 vials; 59) 119,418 vials; 60) 6,727 vials; 61) 1,347,045 ampuls; 62) 139,521 vials; 63) 1,685,494 vials; 64) 43,929 vials; 65) 35,018 bottles; 66) 28,874 bottles; 67) 54,170 vials; 68) 16,984 (10 ml) and 83,115 (30 ml) vials; 69) 18,057 bottles; 70) 67,234 (5 ml), 30,933 (10 ml) and 28,277 (15 ml) bottles; 71) 210,270 vials; 72) 534,974 vials; 73) 78,350 (10 ml) and 161,085 (30 ml) vials; 74) 40,581 vials; 75) 167,238 (5 ml) and 68,219 (10 ml) bottles; 76) 141,019 bottles; 77) 188,280 (0.3 ml) and 15,057 (5 ml) vials; 78) 12,619 vials; 79) 115,140 vials; 80) 745,750 vials; 81) 14,773 vials; 82) 409,785 vials; 83) 36,590 vials; 84) 229,098 vials; 85) 34,072 vials; 86) 280,424 bottles; 87) 338,524 vials; 88) 892,567 (1 ml) and 1,568,078 (5 ml) vials; 89) 1,065,376 vials; 90) 142,586 bottles; 91) 45,948 vials; 92) 24,721 vials; 93) 20,740 vials
REASON Lack of sufficient data from an adequately validated laboratory test method to assure products meet all regulatory requirments; including but not limited to: methods validation and potency.

PRODUCT Allegra-DÆ Extended Release Tablets (Fexofenadine HCL 60 mg and Pseudoephedrine HCL 120 mg), in physician (6ís) samples, 30 and 100 tablet bottles/blister strips, Rx, for the relief of symptoms associated with seasonal allergic rhinitis.
CODE Lot #98069654, EXP 7/99 - 100-tablet blister strip boxes (10/10-tablet strips), NDC #0088-1090-49
Lot #98069082, EXP 7/99 - 30-tablet physician sample bottles, no NDC number
Lot #98071706, EXP 8/99 - 30-tablet physician sample bottles
Lot #98071693, EXP 8/99 - Physician blister samples, no NDC number
Lot #98071987, EXP 8/99 - Physician blister samples
Lot #98073257, EXP 9/99 - 100-tablet bottles, NDC #0088-1090-47
Lot #98073353, EXP 9/99 - 100-tablet bottles
Lot #98073354, EXP 9/99 - 100-tablet bottles
Lot #98072117, EXP 10/99 - Physician blister samples
Lot #98072972, EXP 10/99 - Physician blister samples
Lot #98073503, EXP 10/99 - Physician blister samples
Lot #98073641, EXP 10/99 - 100-tablet bottles
Lot #98073642, EXP 10/99 - 100-tablet bottles
Lot #98073920, EXP 10/99 - 100-tablet bottles
Lot #98074492, EXP 11/99 - 100-tablet bottles.
MANUFACTURER Hoechst Marion Roussel, Inc., Kansas City, Missouri.
DISTRIBUTION Nationwide.
QUANTITY The firm has distributed the following amounts of product: 100-tablet blister strip boxes - 5,326 boxes between 3/5/98-12/22/9830-tablet bottles (physician samples) - 62,514 bottles between 2/13/98-11/3/98Physician blister samples - 129,264 boxes containing 8/3-day starter boxes between 4/3/98-5/27/98100-tablet bottles - 90,676 bottles between 4/27/98-6/22/98.
REASON Dissolution rate failure.