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FDARecalled Jul 5, 2023 · #D-0878-2023

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. Distri...

Hazard

Class II — temporary health risk

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Description

Packaging defect: blister packaging inadequately sealed. Classification: Class II Distribution: Nationwide in the U.S.

Product details

Product
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
Type
Drugs
Manufacturer
The Harvard Drug Group
Model numbers
M04343
UPCs