The Harvard Drug Group: Drug Recall

Recall #D-0878-2023 · 06/16/2023

Class II: Risk

Recall Details

Recall Number: D-0878-2023
Classification: Class II
Product Type: Drug
Recalling Firm: The Harvard Drug Group
Status: Terminated
Date Initiated: 06/16/2023
Location: La Vergne, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3876 cartons

Reason for Recall

Packaging defect: blister packaging inadequately sealed.

Product Description

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

Distribution Pattern

Nationwide in the U.S.

Other Recalls by The Harvard Drug Group

Class III: Low Risk 04/24/2023

Product mixup: one foreign tablet found in product.
Class II: Risk 02/23/2023

Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class II: Risk 02/28/2022

Failed Dissolution Specifications
Class II: Risk 02/24/2022

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class II: Risk 08/06/2021

Failed Dissolution Specifications

View all recalls by The Harvard Drug Group →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.