Key Takeaway

Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd by West-ward Pharmaceutical Corp. was recalled on November 7, 2013. The hazard: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stab...

FDA Drug Class II Terminated

Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd

Recalled: November 7, 2013 ~20,534 bottles units affected D-367-2014

Description

Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.

Hazard / Reason

Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd

Drugs

Company Information

West-ward Pharmaceutical Corp.

Eatontown, NJ, United States

View all 28 recalls by West-ward Pharmaceutical Corp. →

Distribution

Nationwide

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