Home / Recalls / The Harvard Drug Group / D-0652-2021

D-0652-2021 Class II Terminated

Recalled by The Harvard Drug Group — Livonia, MI

Recall Details

Product Type
Drugs
Report Date
July 21, 2021
Initiation Date
July 2, 2021
Termination Date
December 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
504 Cartons of 50 count each; 372 Cartons of 100 count each

Product Description

NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA

Reason for Recall

Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.

Distribution Pattern

Distributed in OH and NJ

Code Information

Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022

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-0031-2026 Class II — Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Pa (October 10, 2025)
  • D-0030-2026 Class II — Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, (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-0878-2023 Class II — Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, (June 16, 2023)
  • 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)