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
Reported: June 20, 2018 Initiated: May 7, 2018 #D-0853-2018
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.
Details
- Recalling Firm
- RIJ Pharmaceutical LLC
- Units Affected
- 8124 bottles
- Distribution
- Nationwide in the USA
- Location
- Middletown, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by RIJ Pharmaceutical LLC. Units affected: 8124 bottles.
Why was this product recalled? ▼
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 20, 2018. Severity: Moderate. Recall number: D-0853-2018.
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