D-0853-2018 Class II Terminated
FDA drug recall D-0853-2018 was initiated by RIJ Pharmaceutical LLC on May 7, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. The recall status is terminated (terminated April 7, 2023). Affected quantity: 8124 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 20, 2018
- Initiation Date
- May 7, 2018
- Termination Date
- April 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8124 bottles
Product Description
Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167
Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 4780111, Exp. 08/19