Home / Recalls / The Harvard Drug Group / D-0878-2023

D-0878-2023 Class II Terminated

Recalled by The Harvard Drug Group — La Vergne, TN

Recall Details

Product Type
Drugs
Report Date
July 5, 2023
Initiation Date
June 16, 2023
Termination Date
April 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3876 cartons

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

Reason for Recall

Packaging defect: blister packaging inadequately sealed.

Distribution Pattern

Nationwide in the U.S.

Code Information

Lot #: M04343, Exp. 04/2024

Other recalls by The Harvard Drug Group

  • D-0383-2026 Class II — Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), R (February 17, 2026)
  • D-0030-2026 Class II — Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, (October 10, 2025)
  • D-0031-2026 Class II — Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Pa (October 10, 2025)
  • D-0507-2025 Class II — Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx (June 19, 2025)
  • D-0508-2025 Class II — Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged (June 19, 2025)
  • D-0570-2023 Class III — Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets p (April 24, 2023)
  • D-0432-2023 Class II — Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Onl (February 23, 2023)
  • D-0649-2022 Class II — PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 bli (February 28, 2022)
  • D-0653-2022 Class II — hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs (February 24, 2022)
  • D-0807-2021 Class II — Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, (August 6, 2021)