Recalls / Class II
Class IID-0338-2015
Product
Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, 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.
- Brand name
- Gabapentin
- Generic name
- Gabapentin
- Active ingredient
- Gabapentin
- Route
- Oral
- NDCs
- 45963-555, 45963-556, 45963-557
- FDA application
- ANDA075350
- Affected lot / code info
- Lot #s: a) G01966A1, Exp 10/2015, b) G02004A1, Exp 03/2016
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
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Elmora Ave, N/A, Elizabeth, New Jersey 07202-1106
Distribution
- Quantity
- 29,622 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-0338-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.