Baxter Pharmaceuticals India Private Limited
Ahmedabad, India · makes it, tests it, packages it, labels it and sterilizes it
Serious problems, FDA action Last FDA inspection Jan 27, 2023. 9 inspections on record, 3 with serious problems.
NDC 36000-033
Metoprolol 5 mg per 5 mL injection
On the label: Baxter Healthcare Corporation.
Where it's made
Recalls
- Oct 15, 2018 · Class III · Terminated
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Lots: 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, A0A0…
Product details
- Generic drug
- Metoprolol: see every company that makes it
- Form
- injection, intravenous
- Strength
- 5 mg per 5 mL
- Approval
- ANDA ANDA078950
- On the market since
- Sep 25, 2012
- Package NDCs
36000-033-10- Official label
- DailyMed (National Library of Medicine), updated May 13, 2024
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