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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #s: a) G01966A1, Exp 10/2015, b) G02004A1, Exp 03/2016
Where it was sold
Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0338-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 15, 2014
- FDA report date
- Jan 14, 2015
- Quantity
- 29,622 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Elizabeth LLC
Original FDA data
Every field from FDA enforcement report D-0338-2015, exactly as published.
Show all FDA fields
- City
- Elizabeth
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70001
- Address
- 200 Elmora Ave
- Code information
- Lot #s: a) G01966A1, Exp 10/2015, b) G02004A1, Exp 03/2016
- Postal code
- 07202-1106
- Report date
- Jan 14, 2015
- Product type
- Drugs
- Recall number
- D-0338-2015
- Classification
- Class II
- Recalling firm
- Actavis Elizabeth LLC
- Product quantity
- 29,622 Bottles
- Termination date
- Nov 20, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Puerto Rico
- Recall initiation date
- Dec 15, 2014
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2015