Sun Pharmaceutical Recalls Riomet Metformin Solution Due to Microbial Contamination
Sun Pharmaceutical Industries Inc. is recalling 13,834 bottles of Riomet (metformin hydrochloride) oral solution due to microbial contamination of the non-sterile product.
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 microbial contamination of a prescription drug, which aligns with the rubric criterion for 'Severe' severity (FDA Class II with potential for adverse health consequences).
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 13,834 bottles of Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles. The product is a prescription-only medication manufactured by Mikart, LLC in Atlanta, GA, and distributed by Sun Pharmaceutical Industries Inc. in Cranbury, NJ.
The recall is being conducted due to microbial contamination of the non-sterile product. The affected lots are J190386A (Exp. 3/2021), X190354A (Exp. 3/2021), J190393A (Exp. 5/2021), A200035A (Exp. 6/2021), B200064A (Exp. 8/2021), and H200236A (Exp. 1/2022). The NDC for the recalled product is 10631-206-02.
The product was distributed nationwide within the United States. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- RIOMET (METFORMIN HYDROCHLORIDE)
- Brand
- RIOMET
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Hazard
- Affected units
- 13,834
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 (11)
- Lot #: J190386A
- X190354A
- Exp. 3/2021
- J190393A
- Exp. 5/2021
- A200035A
- Exp. 6/2021
- B200064A
- Exp. 8/2021
- H200236A
- Exp. 1/2022
Distribution
Distributed nationwide across the United States.
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