Reported Nov 14, 2018 · Terminated
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured…
Baxter Healthcare Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only
- Manufactured forClaris Lifesciences, Inc., North Brunswick, NJ 08902
- ByClaris Injectables Ltd., Gujarat, India
- NDC36000-033-10
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 A061267, A061273,EXP 10/2018 2 A061392, A061395, A061398, A061403, A061407, EXP 11/2018 3 A0A0070, A0A0073, A0A0079, A0A0081, A0A0083, EXP 12/2018 4 A0A0119, A0A0124, A0A0125, A0A0133, A0A0141, A0A0145, A0A0152, EXP 1/2019 5 A0A0247, A0A0252, A0A0253, A0A0292, A0A0293, EXP 2/2019 6 A0A0361, A0A0367, A0A0390, EXP 3/2019 7 A0A0438, A0A0445, A0A0453, A0A0459, EXP 4/2019 8 A0A0547, A0A0551, A0A0554, A0A0630, A0A0631, A0A0637, A0A0638, EXP 5/2019 9 A0A0777, EXP 7/2019 10 A0A0915, A0A0919, A0A0924, A0A0930, EXP 8/2019 11 A0A1094, A0A1097, A0A1110, EXP 11/2019 - Amount recalled
- 402,165 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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