Recalls / Class II
Class IID-0109-2018
Product
Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512
- Brand name
- Riomet
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 10631-206, 10631-238
- FDA application
- NDA021591
- Affected lot / code info
- A lot # 160031A, A160031B; Exp. 11/17
Why it was recalled
Microbial Contamination of Non-Sterile Products
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-04-18
- FDA classified
- 2017-12-13
- Posted by FDA
- 2017-12-20
- Terminated
- 2018-05-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0109-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.