Drug 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
D-0109-2018
Product summary
- Event
- Event 78217
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0109-2018
Official wording
Reason: Microbial Contamination of Non-Sterile Products
Code information: A lot # 160031A, A160031B; Exp. 11/17
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination