Drug recall
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured…
FDA recall event 79979 · Class III · Sun Pharmaceutical Industries, Inc.
Key facts
| Event ID | 79979 |
|---|---|
| Recall numbers | D-0818-2018 |
| Recalling firm | Sun Pharmaceutical Industries, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 26, 2018 |
| Report date | May 23, 2018 |
| Termination date | Feb 28, 2019 |
| City | Cranbury |
| State | NJ |
| Country | United States |
| FEI number | 3005551493 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: