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
1A061267, A061273,EXP 10/2018
2A061392, A061395, A061398, A061403, A061407, EXP 11/2018
3A0A0070, A0A0073, A0A0079, A0A0081, A0A0083, EXP 12/2018
4A0A0119, A0A0124, A0A0125, A0A0133, A0A0141, A0A0145, A0A0152, EXP 1/2019
5A0A0247, A0A0252, A0A0253, A0A0292, A0A0293, EXP 2/2019
6A0A0361, A0A0367, A0A0390, EXP 3/2019
7A0A0438, A0A0445, A0A0453, A0A0459, EXP 4/2019
8A0A0547, A0A0551, A0A0554, A0A0630, A0A0631, A0A0637, A0A0638, EXP 5/2019
9A0A0777, EXP 7/2019
10A0A0915, A0A0919, A0A0924, A0A0930, EXP 8/2019
11A0A1094, 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Baxter Healthcare Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 12, 2022 · Data as of Sep 19, 8:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.