Class III · Low risk Ongoing
busPIRone Hydrochloride Tablets
Reason Subpotent drug
Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
What 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
- Recalling firm
- RIJ Pharmaceutical LLC
- NDC code
- 57896-709-16
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0853-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Iron recalls
See all
Class II · Moderate risk Ongoing
Spironolactone Tablets
Reason Presence of foreign substance: identified as aluminum.
Class II · Moderate risk Ongoing
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
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