The Harvard Drug Group recalls Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Ind…

Recall date

June 16, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0878-2023

FDA classification

Class II

Brand / firm

The Harvard Drug Group

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Packaging defect: blister packaging inadequately sealed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61