Home / Recalls / American Health Packaging / D-1433-2019

D-1433-2019 Class II Terminated

Recalled by American Health Packaging — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
July 3, 2019
Initiation Date
May 13, 2019
Termination Date
September 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,777 cartons

Product Description

Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25

Reason for Recall

GMP Deviations; possible cross contamination of product due to cleaning procedure failure.

Distribution Pattern

Nationwide USA

Code Information

Lot, expiry: Lots 175820, 176569, exp 09/30/2019; Lots 177866, 179627A, 179627B, exp 12/31/2019; Lot 181627, exp 06/30/2020

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  • D-0854-2021 Class II — Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per cas (September 15, 2021)
  • D-0813-2021 Class III — Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Pa (May 12, 2021)
  • D-0232-2021 Class II — Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (January 7, 2021)
  • D-1372-2020 Class III — Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister (June 10, 2020)
  • D-1293-2020 Class II — Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx onl (May 19, 2020)