Home / Recalls / The Harvard Drug Group / D-0806-2021

D-0806-2021 Class II Terminated

Recalled by The Harvard Drug Group — Livonia, MI

Recall Details

Product Type: Drugs
Report Date: September 29, 2021
Initiation Date: July 29, 2021
Termination Date: February 19, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,632 cartons

Product Description

Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

CO, FL, MO, OH

Code Information

Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022

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)