FDA Drug Moderate Class II Terminated

Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.

Reported: January 14, 2015 Initiated: December 15, 2014 #D-0336-2015

Product Description

Reason for Recall

Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

Details

Recalling Firm: Actavis Elizabeth LLC
Units Affected: 10,857 Bottles
Distribution: Puerto Rico
Location: Elizabeth, NJ

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on January 14, 2015. Severity: Moderate. Recall number: D-0336-2015.

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Product Description

Reason for Recall

Details

Frequently Asked Questions

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