Why it was recalled
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Product description
Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5.
Lot numbers, UPCs & expiration codes
Lot #: GESB14011-A, Exp 12/15
Where it was sold
Nationwide
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-0330-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 17, 2014
- FDA report date
- Jan 14, 2015
- Quantity
- 24,816 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-0330-2015, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69807
- Address
- 6 Wheeling Road
- Code information
- Lot #: GESB14011-A, Exp 12/15
- Postal code
- 08810
- Report date
- Jan 14, 2015
- Product type
- Drugs
- Recall number
- D-0330-2015
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc
- Product quantity
- 24,816 bottles
- Termination date
- May 23, 2016
- Reason for recall
- Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 17, 2014
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2015