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
Reported: October 7, 2020 Initiated: September 23, 2020 #D-0002-2021
Product Description
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
Reason for Recall
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 747 bottles
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 747 bottles.
Why was this product recalled? ▼
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 7, 2020. Severity: Moderate. Recall number: D-0002-2021.
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