WEEK ENDING OCTOBER 1

PRODUCT TUSSIONEX Pennkinetic (hydrocodone polistirex), extended- release suspension (Hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and Chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate), in 473 mL bottle, Rx medication for relief of cough and upper respiratory symptoms associated with allergy or a cold.NDC #53014-548-67
CODE
90299, EXP 04/01
90300, EXP 04/01
90301, EXP 04/01
90302, EXP 04/01
90303, EXP 04/01
90309, EXP 05/01
90310, EXP 05/01.
MANUFACTURER Medeva Pharmaceuticals, Inc., Rochester, New York.
DISTRIBUTION Nationwide.
QUANTITY Lot 90299: 7,491 units were distributed between 5/17/99 and 5/19/99.
Lot 90300: 7,622 units were distributed between 5/18/99 and 5/28/99.
Lot 90301: 7,702 units were distributed between 5/28/99 and 6/10/99.
Lot 90302: 7,714 units were distributed between 5/24/99 and 6/15/99.
Lot 90303: 3,166 units were distributed on 6/15/99
Lot 90309: 7,446 units were distributed between 5/25/99 and 6/10/99.
Lot 90310: 7,637 units were distributed between 6/10/99 and 6/30/99.
REASON Microbial contamination (acetobacter SPP).
 

WEEK ENDING OCTOBER 8

PRODUCT PRE-PENÆ Skin Test Antigen, (benzylpenicilloyl polylysine injection, USP), in single dose ampuls (5 per carton), Rx used in assessing a patient's allergy status to penicillin. NDC #0091-1640-05.
CODE Lot #33911, 33912, 33913 EXP 10/99.
MANUFACTURER Hollister-Stier Laboratories LLC, Spokane, Washington.
DISTRIBUTION Nationwide and international.
QUANTITY 500 units of lot 33911, 4,716 units of lot 33912 and 200 units of lot 33913 were distributed.
REASON Subpotency (30 month stability testing).
 

WEEK ENDING OCTOBER 22

PRODUCT a) Cefazolin Sodium, USP, Rx, Sterile,10 grams, 100 mL vial; b) Cefazolin Sodium, USP, Rx, Sterile,1 gram, 100 mL vial, c) Ampicillin Sodium, USP, Rx, Sterile, in 10g, 100 mL vial.
CODE a) Lot# 9901006 (Control #9M02727) EXP 12/2000 - NDC 0209-1100-52; b) Lot # 9801005 (Control #8M92223) EXP 12/99 - NDC 0209-1000-42; c) Lot# 9710002 (Control #7J02055) EXP 09/2000, NDC 0209-0450-52. (Note: All products are identified on the label by the Control Number. The firm's lot number does not appear on the label).
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY Lot# 9801005 (Control #8M92223)- 5,810 trays, 10 vials per tray Lot# 9901006 (Control No. 9M02727)- 1,151 trays, 10 vials per tray Lot# 9710002 (Control No. 7J02055)- 2,496 trays, 10 vials per tray were distributed.
REASON Potency problems; super and/or subpotent.

PRODUCT Lorazepam Injection, USP, 2 mg/mL, in 10 mL multiple dose vial, Rx, indicated in adult patients for preanesthetic medication, producing sedation, relief of anxiety, and a decreased ability to recall events related to the day of surgery.
CODE Lot# 9806034 (Control #8E02499) EXP 05/2000 NDC 0209-4581-20. (Note: All products are identified on the label by the Control Number. The firm's lot number does not appear on the label).
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY 10,591 cartons, 1 multiple dose vial per carton were distributed.
REASON Superpotency.
 

WEEK ENDING OCTOBER 29

PRODUCTS a) Penicillin G Potassium for Injection, 20 Million Units, 100 mL vial, Rx bactericidal for IM or IV use. b) Cefuroxime Sodium, USP, Sterile, 1.5 grams, 20 mL vial, Rx semi-synthetic broad spectrum cephalosporin antibiotic for IM or IV use c) Cefuroxime Sodium, USP, Sterile, 750 mg, 10 mL vial, Rx semi-synthetic broad spectrum cephalosporin antibiotic for IM or IV use. d) Cefazolin Sodium, USP, Sterile, 1 gram, 10 mL vial, Rx semi-synthetic cephalosporin for IM or IV use e) Ampicillin Sodium, USP, Sterile, 250 mg, 6 mL vial, Rx synthetic penicillin for IM or IV use f) Ampicillin Sodium, USP, Sterile, 500 mg, 6 mL vial, Rx synthetic penicillin for IM or IV use g) Oxacillin Sodium for Injection, USP, 10 grams, 100 mL vial, Rx penicillinase-resistant, acid resistant, semi-synthetic penicillin.
CODE a) Lot #9801015 (Control #8M12221) EXP 12/01 NDC 0209-8580-22
b) Lot #9806019 (Control #8E02475) EXP. 00 MA
c) Lot #9810030 (Control #8J02600) EXP 09/2000 NDC 0209-1132-22
d) Lot#9902058 (Control #9A12836) EXP 01/01 NDC 0209-0900-20 Lot #9902059 (Control #9A12837) EXP 01/01 NDC 0209-0900-20Lot #9805020 (Control #8D02403) EXP 04/2000 NDC 0209-1000-42
e) Lot #9902054A (Control #9A12833) EXP 01 JA Lot #9902054B (Control #9A22834) EXP 01/2002 NDC 0209-0100-22
f) Lot #9902053A (Control #9A12831) EXP 01 JA Lot #9902053B (Control #9A22832) EXP 01/2002 NDC 0209-0150-22
g) Lot #9704019 (Control #7D01760) EXP 04/00 NDC 0209-8300-52
Note: All products are identified on the label by the Control Number. The firm's lot number does not appear on the label.
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
DISTRIBUTION Nationwide and Canada.
QUANTITY The following amounts per lot were distributed:
Penicillin: Lot# 9801015 (Control No. 8M12221) 2,523 trays, 10 vials per tray
Cefuroxime Sodium: Lot# 9806019 (Control #8E02475) 3,512 trays, 10 vials per tray Lot# 9810030 (Control #8J02600)1,286 trays, 10 vials per tray
Cefazolin Sodium: Lot#9902058 (Control #9A12836) 4,661 trays, 25 vials per tray Lot#9902059 (Control #9A12837) 5,124 trays, 25 vials per tray (note: 3 trays are on hand at the firm's distribution center in Brewster, NY) Lot# 9805020 (Control No. 8D02403) - 6,040 trays, 10 vials per tray
Ampicillin Sodium: Lot# 9902054A (Control No. 9A12833) 1,280 trays, 10 vials per tray Lot# 9902054B (Control No. 9A22834) - 9,576 trays, 10 vials per tray (Note: this lot was shipped from Marsam to their distribution center in Brewster, NY and is on hand at that facility). Lot# 9902053A (Control No. 9A12831) - 2,201trays, 10 vials per tray Lot# 9902053B (Control No. 9A22832) - 8,910 trays, 10 vials per tray (note: 7,315 trays are on hand at the firm's distribution center in Brewster, NY).
Oxacillin: Lot# 9704019 (Control No. 7D01760) - 445 trays, 10 vials per tray.
REASON Microbial contamination revealed during initial sterility testing (at release).

PRODUCTS Nafcillin Sodium for Injection, USP, in 100 mL vial, Rx intended for preparing IV admixtures only. NDC #0209-7250-52.
CODE Lot # 9711018 (Control # 7K02124), EXP 10/2000.
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY 613 trays (10 vials per tray) were distributed.
REASON Failure to meet particle size specification.

PRODUCTS Various Rx drugs, some multiple potencies. Products were packaged/labeled under various labels which included Marsam Pharmaceuticals, Cherry Hill, NJ label, Schein Canada label, Marsam Canada label (batches made in 1996), Schein Pharmaceutical, Florham Park, NJ label, Apothecon label, VHA label, and Agvar Chemical label as specified below:
Ampicillin Sodium, USP, Sterile, 10 gram vial
Ampicillin Sodium, USP, Sterile, 2 gram vial
Ampicillin Sodium, USP, Sterile, 1 gram vial
Ampicillin Sodium, USP, Sterile, 500mg vial
Ampicillin Sodium, USP, Sterile, 250 gram vial
Ampicillin Sodium, USP, Sterile, 125 gram vial
Cefaclor Capsules, USP, 250 mg
Cefaclor Capsules, USP, 500mg
Cefaclor for Oral Suspension, USP 125 mg
Cefaclor for Oral Suspension, USP 187 mg
Cefaclor for Oral Suspension, USP 250 mg
Cefaclor for Oral Suspension, USP 375 mg
Cefazolin Sodium, USP, Sterile, 20 gram
Cefazolin Sodium, USP, Sterile, 10 gram
Cefazolin Sodium, USP, Sterile, 1 gram
Cefazolin Sodium, USP, Sterile, 500 mg
Cerfuroxime Sodium, USP, Sterile, 7.5 grams
Cerfuroxime Sodium, USP, Sterile, 1.5 grams
Cerfuroxime Sodium, USP, Sterile, 750 mg
Isoflurane USP , 99.9 %, 100 and 250 mL bottles
Nafcillin Sodium for Injection, USP, 10 gram
Nafcillin Sodium for Injection, USP, 2 gram
Nafcillin Sodium for Injection, USP, 4 gram
Nafcillin Sodium for Injection, USP, 1 gram
Nafcillin Sodium for Injection, USP, 500 mg
Oxacillin Sodium for Injection, USP, 10 gram
Oxacillin Sodium for Injection, USP, 2 gram
Oxacillin Sodium for Injection, USP, 1 gram
Oxacillin Sodium for Injection, USP, 500 mg
Penicillin G Potassium for Injection, USP, 20 million units
Penicillin G Potassium for Injection, USP, 10 million units
Penicillin G Potassium for Injection, USP, 5 million units
Penicillin G Potassium for Injection, USP, 1 million units
Penicillin G Sodium for Injection, USP, 10 million units
Penicillin G sodium for Injection, USP, 5 million units
Penicillin G Sodium for Injection, USP, 1 million units.
CODE All lots with expiration date.
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
DISTRIBUTION Nationwide and Canada.
QUANTITY Undetermined.
REASON Current good manufacturing practice deviations.

PRODUCTS Nafcillin Sodium for Injection, Rx semi-synthetic penicillin derived from the penicillin nucleus for IM or IV administration: a) Nafcillin Sodium for Injection, USP, 500 mg, 6 mL vial, Control/Lot No. 7L02199 b) Nafcillin Sodium for Injection, USP, 1g, 20 and 100 mL vials; c) Nafcillin Sodium for Injection, USP, 2g, 20 and 100 mL vials; d) Nafcillin Sodium for Injection, USP,10g, 100 mL vial, 4 lot numbers e) Ampicillin Sodium, USP Sterile, 1g, 10mL vial, Rx synthetic penicillin indicated for treatment of moderately severe and severe infections caused by susceptible strains of numerous (mostly gram-positive, but also specific gram-negative) organisms for IM or IV administration; f) Cefazolin Sodium, USP, Sterile, 1 gram, 10 mL vial, Rx a semi-synthetic cephalosporin for IM or IV administration and is indicated in the treatment of serious infections.
CODE Nafcillin Sodium for Injection:
Lot # 9712026 (Control # 7L02199), EXP 11/2000- NDC 0209-6900-22
Lot # 9701040 (Control # 7A01645), EXP 01/2000-NDC 0209-6950-22
Lot # 9710018 (Control # 7J02067), EXP 09/2000- NDC 0209-6950-22
Lot # 9712024 (Control # 7L02191), EXP 11/2000- NDC 0209-6950-22
Lot # 9711030 (Control # 7K02143), EXP 10/2000- NDC 0209-6950-22
Lot # 9710049 (Control # 7J02100), EXP 09/2000- NDC 0209-7000-42
Lot # 9702001 (Control # 7B01647), EXP 02/2000- NDC 0209-7100-22
Lot # 9702002 (Control # 7B01648), EXP 02/2000- NDC 0209-7100-22
Lot # 9802031 (Control # 8A12261), EXP 01/01- NDC 0209-7100-22
Lot # 9711015 (Control # 7K02121), EXP 10/2000- NDC 0209-7150-42
Lot # 9701037 (Control # 7A01643), EXP 01/2000- NDC 0209-7250-52
Lot # 9701038 (Control # 7A01644), EXP 01/2000- NDC 0209-7250-52
Lot # 9703050 (Control # 7C01722), EXP 03/2000- NDC 0209-7250-52
Lot # 9711019 (Control # 7K02125), EXP 10/2000- NDC 0209-7250-52.
Ampicillin Sodium:
Lot #9809031 (Control #8H12564) EXP 08/01- NDC 0209-0250-22;
Lot #9807019 (Control #8F02494) EXP 00 JN- no NDC number
Lot #9806017 (Control #8E02493) EXP 00 MA- no NDC number
Cefazolin Sodium:
Lot #9806023 (Control #8E02431) EXP 05/2000 - NDC 0209-0900-24
Lot #9705027 (Control #7E91814) EXP 05/99- NDC 0209-1000-42
(Note: the Control Number identifies All products on the label. The firm's lot number does not appear on the label).
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
DISTRIBUTION (a-d) Nationwide; e) Canada; f) Nationwide.
QUANTITY The following amounts of Nafcillin Sodium for Injection, USP (per lot) were distributed:
Lot # 9712026- 1,981 trays, 10 vials per tray
Lot # 9701040- 3,268 trays, 10 vials per tray
Lot # 9710018- 2,100 trays, 10 vials per tray
Lot # 9712024- 2,184 trays, 10 vials per tray
Lot # 9711030- 2,193 trays, 10 vials per tray
Lot # 9710049- 951 trays, 10 vials per tray
Lot # 9702001- 1,051 trays, 10 vials per tray
Lot # 9702002- 2,585 trays, 10 vials per tray
Lot # 9802031- 2,814 trays, 10 vials per tray
Lot # 9711015- 1,055 trays, 10 vials per tray
Lot # 9701037- 585 trays, 10 vials per tray
Lot # 9701038- 573 trays, 10 vials per tray
Lot # 9703050- 475 trays, 10 vials per tray
Lot # 9711019- 602 trays, 10 vials per tray
The following amounts of Sterile Ampicillin Sodium, USP (per lot) were distributed:
Lot # 9809031- 5,093 trays, 10 vials per tray
Lot # 9807019- 6,264 trays, 10 vials per tray
Lot # 9806017- 6,000 trays, 10 vials per tray
The following amounts of Sterile Cefazolin Sodium, USP (per lot) were distributed to consignees:
Lot # 9806023- 4,846 trays, 25 vials per tray **Note: this lot was distributed to Schein Pharm., Brewster, NY only. Not yet distributed to customers.
Lot # 9705027- 2,299 trays, 10 vials per tray.
REASON Unapproved (ANDA) raw material assay calculations (averaging).

PRODUCTS Sterile Cefazolin Sodium, USP, sterile, Rx semi-synthetic cephalosporin for IM or IV administration and is indicated in the treatment of serious infections:
a) 1 gram in 10 mL vial; b) 10 gram, in 100 ml vial.
CODE a) Lot # 9706054 (Control #7F91884) EXP 06/99, NDC 0209-0900-24; b) Lot #9705035 (Control # 7E91833) EXP 05/99, NDC 0209-1100-52. (Note: the Control Number identifies All products on the label. The firm's lot Number does not appear on the label).
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
DISTRIBUTION a) Nationwide; b) Massachusetts.
QUANTITY a) 4,878 trays (25 vials per tray); b) 1,248 (10 vials per tray) were distributed.
REASON Failure to meet pH specification.