Home / Recalls / Watson Laboratories Inc / D-823-2013

D-823-2013 Class III Terminated

Recalled by Watson Laboratories Inc — Corona, CA

Recall Details

Product Type
Drugs
Report Date
July 31, 2013
Initiation Date
July 19, 2013
Termination Date
July 29, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,260 bottles

Product Description

Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.

Reason for Recall

Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.

Distribution Pattern

Nationwide

Code Information

Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13

Other recalls by Watson Laboratories Inc

  • D-1053-2014 Class II — Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 c (January 15, 2014)
  • D-397-2014 Class II — Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured (December 23, 2013)
  • D-66360-001 Class II — Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 (September 23, 2013)
  • D-66251-001 Class II — Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, R (September 13, 2013)
  • D-1061-2013 Class III — Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Cou (August 30, 2013)
  • D-205-2013 Class II — ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 table (February 13, 2013)
  • D-204-2013 Class II — Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson (February 8, 2013)
  • D-203-2013 Class II — Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson (February 8, 2013)
  • D-094-2013 Class III — Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0 (December 13, 2012)
  • D-013-2013 Class II — Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, ine (October 19, 2012)