Recalls / Class II
Class IID-0337-2015
Product
Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, 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, NDC 45963-556-11
- Brand name
- Gaba 300-ezs
- Generic name
- Gabapentin
- NDC
- 59088-725
- Affected lot / code info
- Lot #s: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015
Why it was recalled
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.
Recalling firm
- Firm
- Actavis Elizabeth LLC
- Manufacturer
- PureTek Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Elmora Ave, N/A, Elizabeth, New Jersey 07202-1106
Distribution
- Quantity
- 24,240 Bottles
- Distribution pattern
- Puerto Rico
Timeline
- Recall initiated
- 2014-12-15
- FDA classified
- 2015-01-08
- Posted by FDA
- 2015-01-14
- Terminated
- 2015-11-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0337-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.