Geritrex Recalls Iron Elixir Due to Potential Microbial Contamination
Geritrex, LLC is recalling Preferred Plus Pharmacy Iron Elixir due to cGMP deviations that may result in microbial contamination.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves potential microbial contamination, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant health impact).
Plain-English summary
Geritrex, LLC is recalling Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL). The product is distributed by Geri-care Pharmaceuticals Corp. and carries the NDC 52807-177-16.
The recall is being conducted because of Current Good Manufacturing Practice (cGMP) deviations. These deviations mean that the products may have microbial contamination. The specific lot number is 70601, with an expiration date of 6/19. A total of 3,864 bottles are affected.
The product was distributed nationwide in the U.S.A. Consumers should check their inventory for this specific product and lot number. If found, they should stop using the product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16
- Manufacturer
- Geritrex, LLC
- Category
- Drug — Iron Supplement
- Hazard
- Affected units
- 3,864
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 #: 70601
- Exp 6/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Geritrex, 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.
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