D-0537-2018 Class II Terminated
FDA drug recall D-0537-2018 was initiated by American Pharmaceutical Ingredients LLC on Feb 9, 2018 and is designated Class II. 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. The recall status is terminated (terminated Dec 2, 2019). Affected quantity: 10769 g.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 28, 2018
- Initiation Date
- Feb 9, 2018
- Termination Date
- Dec 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10769 g
Product Description
Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), 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) b) 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019; 051515-3, Exp. 02/28/2019; c) 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019 d) 012216-1, Exp. 12/31/2019; 051515-2, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020; e) 051515-2, exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021; f) 012216-1, Exp. 12/31/2019; 051515-1, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0537-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026