FDA recall D-0878-2023

The Harvard Drug Group · Class II · drug

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

Reason for recall

Packaging defect: blister packaging inadequately sealed.

Distribution

Nationwide in the U.S.

Key facts

Status: Terminated
Initiation date: 2023-06-16
Report date: 2023-07-05
Termination date: 2024-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

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