Riomet recall: Labeling Error
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
Why was Riomet recalled?
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Quantity
- 19,758 473 mL bottles
- Distribution
- US Nationwide in the USA
- Recall date
- May 23, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)