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Recall Observatory FDA recall evidence

Drug 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

D-0818-2018

April 26, 2018

Class III

Product summary

Firm
Sun Pharmaceutical Industries, Inc.
Event
Event 79979
Status
Terminated
Classification
Class III
Quantity
19,758 473 mL bottles
Official record key
drug-enforcement:D-0818-2018

Official wording

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

Code information: 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.

Distribution pattern: US Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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