Sun Pharmaceutical Industries, Inc.: 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:

Is my product affected?

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

• Brand RIOMET

Check against the official notice below — it lists the full affected range.

What happened

Sun Pharmaceutical Industries, Inc. is recalling Riomet (metformin hydrochloride oral solution), 500 mg/5 mL, distributed nationwide in 473 mL plastic bottles. The recall affects approximately 19,758 bottles across six lot numbers with expiration dates ranging from June 9, 2019 to July 13, 2019. The recall was initiated due to labeling discrepancies found in the patient literature included with the medication.

The source document does not specify what remedy consumers should pursue or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

Details from the source

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. Distribution: US Nationwide in the USA Quantity: 19,758 473 mL bottles Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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