FDAFDA · Food and drugs·Recall number D-0002-2021
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17
Published October 7, 2020 · Recall initiated: September 23, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide
- Lot
- Lot #: AB06381; Exp 10/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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