D-0494-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 28, 2018
- Initiation Date
- February 9, 2018
- Termination Date
- December 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 606950
Product 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
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.
Distribution Pattern
Nationwide within USA.
Code Information
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