Reported May 23, 2018 · Terminated
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by:…
Sun Pharmaceutical Industries, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
- Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle
- Manufactured byMikart, Inc., Atlanta, GA 30318
- Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
- Lot codes and dates
- Lot Numbers
E170210AEXP 06/09/2019F170214A07/05/2019F170223AEXP 07/06/2019F170224A EXP 07/10/2019F170231AEXP 07/12/2019F170232A EXP 07/13/2019
- Lot Numbers
- Amount recalled
- 19,758 473 mL bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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