Recalls / Class III
Class IIID-0222-2019
Product
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10
- Brand name
- Metoprolol
- Generic name
- Metoprolol Tartrate
- Active ingredient
- Metoprolol Tartrate
- Route
- Intravenous
- NDC
- 36000-033
- FDA application
- ANDA078950
- Affected lot / code info
- Lot #S: A061267, A061273,EXP 10/2018; A061392, A061395, A061398, A061403, A061407, EXP 11/2018; A0A0070, A0A0073, A0A0079, A0A0081, A0A0083, EXP 12/2018; A0A0119, A0A0124, A0A0125, A0A0133, A0A0141, A0A0145, A0A0152, EXP 1/2019; A0A0247, A0A0252, A0A0253, A0A0292, A0A0293, EXP 2/2019; A0A0361, A0A0367, A0A0390, EXP 3/2019; A0A0438, A0A0445, A0A0453, A0A0459, EXP 4/2019; A0A0547, A0A0551, A0A0554, A0A0630, A0A0631, A0A0637, A0A0638, EXP 5/2019; A0A0777, EXP 7/2019; A0A0915, A0A0919, A0A0924, A0A0930, EXP 8/2019; A0A1094, A0A1097, A0A1110, EXP 11/2019;
Why it was recalled
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 402,165 vials
- Distribution pattern
- Distributed nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-10-15
- FDA classified
- 2018-11-07
- Posted by FDA
- 2018-11-14
- Terminated
- 2022-08-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0222-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.