Sun Pharmaceutical Recalls Riomet Metformin Solution Due to Microbial Contamination
Sun Pharmaceutical Industries is recalling Riomet (metformin hydrochloride) oral solution due to microbial contamination. The recall covers specific lots of the cherry-flavored prescription liquid.
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. According to the rubric, an FDA Class II recall with potential for adverse health consequences (microbial contamination) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High risk due to the specific agency classification.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg/5 mL. The affected products are available in 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles. The recall is being conducted because of microbial contamination of the non-sterile product.
The recall affects lots 160031A and A160031B with an expiration date of 11/17. The product was manufactured for Ranbaxy Laboratories Inc. and distributed by Sun Pharmaceutical Industries. The distribution pattern is listed as nationwide.
Consumers and healthcare providers should stop using the affected lots of Riomet and return them to the pharmacy or point of purchase for a refund or replacement. This recall is classified as Class II by the FDA, indicating a situation where 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.
- Category
- Drug — Prescription Liquid
- Hazard
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 (3)
- A lot # 160031A
- A160031B
- Exp. 11/17
Distribution
Distributed nationwide across the United States.
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