FDAFDA · Food and drugs·Recall number D-0818-2018
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
Published May 23, 2018 · Recall initiated: April 26, 2018
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
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RIOMET
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- US Nationwide in the USA
- Lot
- Lot Numbers: E170210A, EXP 06/09/2019; F170214A, 07/05/2019; F170223A, EXP 07/06/2019; F170224A EXP 07/10/2019; F170231A , EXP 07/12/2019; F170232A EXP 07/13/2019.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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