The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0853-2018·Announced 2018-06-20

RIJ Recalls Gericare Iron Supplement Elixir Due to Microbial Count

RIJ Pharmaceutical LLC is recalling Gericare Iron Supplement Elixir due to out-of-specification microbial counts in a water sample.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations involving microbial counts in a water sample, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported illness.

Plain-English summary

RIJ Pharmaceutical LLC is recalling Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles. The recall involves 8,124 bottles distributed nationwide in the USA. The specific lot number is 4780111 with an expiration date of 08/19.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an out-of-specification total aerobic microbial count was detected in a water sample. The FDA has classified this recall as Class II.

Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches these details, it should be returned to the point of purchase or disposed of according to local regulations.

The recalled product

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
Manufacturer
RIJ Pharmaceutical LLC
Category
Drug — Supplement
Hazard
Affected units
8,124

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 4780111
  • Exp. 08/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by RIJ Pharmaceutical LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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