Home / Recalls / West-ward Pharmaceutical Corp. / D-131-2013

D-131-2013 Class II Terminated

Recalled by West-ward Pharmaceutical Corp. — Eatontown, NJ

Recall Details

Product Type
Drugs
Report Date
January 30, 2013
Initiation Date
December 7, 2012
Termination Date
August 4, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43,075 bottles

Product Description

Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.

Reason for Recall

Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 68478A, 69059A, 69059B, Exp 01/16

Other recalls by West-ward Pharmaceutical Corp.

  • D-0008-2017 Class II — PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward P (October 3, 2016)
  • D-1139-2015 Class III — Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, (May 13, 2015)
  • D-0172-2015 Class II — VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count (October 2, 2014)
  • D-1414-2014 Class II — Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0 (May 20, 2014)
  • D-367-2014 Class II — Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pha (November 7, 2013)
  • D-66447-002 Class II — Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose (September 23, 2013)
  • D-66447-001 Class II — Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose (September 23, 2013)
  • D-883-2013 Class II — Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) a (July 30, 2013)
  • D-853-2013 Class II — Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC (July 30, 2013)
  • D-839-2013 Class II — VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets (June 4, 2013)