🔍 RecallPedia

Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Class I - Dangerous
💊 Drugs Recalled: February 9, 2018 American Pharmaceutical Ingredients Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: a) 031116-7, exp. 03/31/2019; 112816-1, Exp. 03/01/2020 b) 011717-2, 051617-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-7, exp. 03/31/2019; 051215-1, exp. 03/05/2018; 063015-1, Exp. 05/19/2018; 092315-1, Exp. 07/17/2018; 111615-6, Exp. 08/27/2018; 112816-1, Exp. 03/01/2020; c) 011717-7, 011717-2, 051617-1, 082117B-1, Exp. 04/30/2020; ; 031116-2, 031116-4, 031116-5, 031116-7, Exp.. 03/31/2019; 051215-1, Exp. 03/05/2018; 092315-2, Exp. 07/17/2018; 111615-4, 111615-5, Exp. 08/27/2018; 112816-1, 112816-2, Exp. 03/01/2020; d) 011717-7, 051617-1, 082117B-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-3, 031116-4, 031116-6, 031116-7, Exp. 03/31/2019; 051215-1, 051215-3, Exp. 03/05/2018; 063015-2, Exp. 05/19/2018; 111615-1, 111615-2, 111615-3, Exp. 08/27/2018; 112816-2, Exp. 03/01/2020
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
American Pharmaceutical Ingredients LLC
Reason for Recall:
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Product Codes/Lot Numbers:

Lot #: a) 031116-7, exp. 03/31/2019; 112816-1, Exp. 03/01/2020 b) 011717-2, 051617-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-7, exp. 03/31/2019; 051215-1, exp. 03/05/2018; 063015-1, Exp. 05/19/2018; 092315-1, Exp. 07/17/2018; 111615-6, Exp. 08/27/2018; 112816-1, Exp. 03/01/2020; c) 011717-7, 011717-2, 051617-1, 082117B-1, Exp. 04/30/2020; ; 031116-2, 031116-4, 031116-5, 031116-7, Exp.. 03/31/2019; 051215-1, Exp. 03/05/2018; 092315-2, Exp. 07/17/2018; 111615-4, 111615-5, Exp. 08/27/2018; 112816-1, 112816-2, Exp. 03/01/2020; d) 011717-7, 051617-1, 082117B-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-3, 031116-4, 031116-6, 031116-7, Exp. 03/31/2019; 051215-1, 051215-3, Exp. 03/05/2018; 063015-2, Exp. 05/19/2018; 111615-1, 111615-2, 111615-3, Exp. 08/27/2018; 112816-2, Exp. 03/01/2020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0494-2018

Related Recalls

Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

American Pharmaceutical Ingredients

Class I - Dangerous

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Feb 9, 2018 Prescription Drugs Nationwide View Details →