FDA-Drug2023-07-05Class II

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

The Harvard Drug Group
Hazard

Packaging defect: blister packaging inadequately sealed.

Sold states
Nationwide in the U.S.
Affected count
3876 cartons
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0878-2023

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