Drug product
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
D-0853-2018
Product summary
- Event
- Event 80053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8124 bottles
- Official record key
drug-enforcement:D-0853-2018
Official wording
Reason: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Code information: Lot #: 4780111, Exp. 08/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
out of specification