Home / Recalls / Actavis Inc / D-1457-2016

D-1457-2016 Class II Terminated

Recalled by Actavis Inc — Parsippany, NJ

Recall Details

Product Type: Drugs
Report Date: August 24, 2016
Initiation Date: June 30, 2016
Termination Date: July 3, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 167,152 bottles

Product Description

Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30

Reason for Recall

Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.

Distribution Pattern

Nationwide

Code Information

Lot # 3132593, 3132594, 3134420, 3134421,3134422, Exp. 02/17

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D-1448-2016 Class II — Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, R (July 11, 2016)
D-1148-2015 Class III — Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day (June 4, 2015)
D-0406-2015 Class II — Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx On (February 12, 2015)
D-0396-2015 Class II — Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx On (February 12, 2015)
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