D-0818-2018 Class III Terminated
FDA drug recall D-0818-2018 was initiated by Sun Pharmaceutical Industries, Inc. on Apr 26, 2018 and is designated Class III. 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. The recall status is terminated (terminated Feb 28, 2019). Affected quantity: 19,758 473 mL bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 23, 2018
- Initiation Date
- Apr 26, 2018
- Termination Date
- Feb 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,758 473 mL bottles
Product Description
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
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 Pattern
US Nationwide in the USA
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0818-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026