Recalls / Class III
Class IIID-0245-2019
Product
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
- Affected lot / code info
- Lot #: A0A0253, Exp. 02/2019; Lot #: B0369427-112717, Exp. 08/2019
Why it was recalled
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 1 vial
- Distribution pattern
- 1 vial was distributed to a medical facility in Mayville, NY.
Timeline
- Recall initiated
- 2018-10-26
- FDA classified
- 2018-11-14
- Posted by FDA
- 2018-11-21
- Terminated
- 2019-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0245-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.