Reported Oct 7, 2020 · Terminated
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For
- Oral Use Only Rx Only Manufactured bySun Pharmaceuticals Industries Limited Mohali
- India Distributed bySun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17
- Lot codes and dates
Lot #: AB06381Exp 10/2021
- Amount recalled
- 747 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
This product could cause temporary or reversible health problems — stop using it.
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