Sun Pharma Recalls Riomet Metformin Solution Due to Labeling Errors
Sun Pharmaceutical Industries is recalling Riomet (metformin hydrochloride) oral solution due to identified labeling discrepancies in the patient literature.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is limited to labeling discrepancies in patient literature.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 19,758 bottles of Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottles. The recall was initiated in response to identified labeling discrepancies in the patient literature.
The affected product is distributed nationwide in the USA. The specific lot numbers involved are E170210A, F170214A, F170223A, F170224A, F170231A, and F170232A, with expiration dates ranging from June 2019 to July 2019.
Consumers should check their Riomet bottles for these specific lot numbers and expiration dates. If the product matches the recalled lots, they should contact their pharmacist or Sun Pharmaceutical Industries for further instructions.
The recalled product
- Product
- RIOMET (METFORMIN HYDROCHLORIDE)
- Brand
- RIOMET
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Drug
- 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 (10)
- Lot Numbers: E170210A
- EXP 06/09/2019
- F170214A
- 07/05/2019
- F170223A
- EXP 07/06/2019
- F170224A EXP 07/10/2019
- F170231A
- EXP 07/12/2019
- F170232A EXP 07/13/2019.
Distribution
Distributed nationwide across the United States.
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