Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
Reported: May 23, 2018 Initiated: April 26, 2018 #D-0818-2018
Product Description
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
Reason for Recall
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 19,758 473 mL bottles
- Distribution
- US Nationwide in the USA
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 19,758 473 mL bottles.
Why was this product recalled? ▼
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 23, 2018. Severity: Low. Recall number: D-0818-2018.
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