Why it was recalled
Microbial Contamination of Non-Sterile Products
Product description
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
Lot numbers, UPCs & expiration codes
A lot # 160031A, A160031B; Exp. 11/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0109-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 18, 2017
- FDA report date
- Dec 20, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0109-2018, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78217
- Address
- 270 Prospect Plains Rd
- Code information
- A lot # 160031A, A160031B; Exp. 11/17
- Postal code
- 08512-3605
- Report date
- Dec 20, 2017
- Product type
- Drugs
- Recall number
- D-0109-2018
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Termination date
- May 30, 2018
- Reason for recall
- Microbial Contamination of Non-Sterile Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 18, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 13, 2017