Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: Metoprolol Tartrate Injection Recalled for Out-of-Specification pH Levels

Agency Publication Date: November 6, 2018

Summary

Baxter Healthcare Corporation is recalling 402,165 vials of Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL) because the pH level of the solution may shift upward over time, exceeding the required safety specifications during its shelf life. This prescription medication is used to treat heart conditions and was manufactured for Claris Lifesciences and produced by Claris Injectables. If you have this medication, you should contact your healthcare provider or pharmacist immediately for guidance and return any unused product to the place of purchase for a refund.

Risk

A shift in the pH level of an injectable medication can change the stability and effectiveness of the drug, potentially causing localized irritation or reducing the intended therapeutic effect when administered to a patient.

What You Should Do

Check your medication vials for Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL) in 5 mL single-use glass vials with NDC 36000-033-10.
Verify if your product matches one of the affected lot numbers and expiration dates: 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).
If you have an affected vial, contact your healthcare provider or pharmacist immediately to discuss alternative treatments and ensure you do not use the out-of-specification medication.
Return any unused vials to the pharmacy or place of purchase to receive a refund.
Contact Baxter Healthcare Corporation at their headquarters at 1-888-229-0001 for more information regarding this recall.
For additional consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL)

Model:

NDC: 36000-033-10

Lot Numbers:

A061267 (Exp 10/2018)

A061273 (Exp 10/2018)

A061392 (Exp 11/2018)

A061395 (Exp 11/2018)

A061398 (Exp 11/2018)

A061403 (Exp 11/2018)

A061407 (Exp 11/2018)

A0A0070 (Exp 12/2018)

A0A0073 (Exp 12/2018)

A0A0079 (Exp 12/2018)

A0A0081 (Exp 12/2018)

A0A0083 (Exp 12/2018)

A0A0119 (Exp 1/2019)

A0A0124 (Exp 1/2019)

A0A0125 (Exp 1/2019)

A0A0133 (Exp 1/2019)

A0A0141 (Exp 1/2019)

A0A0145 (Exp 1/2019)

A0A0152 (Exp 1/2019)

A0A0247 (Exp 2/2019)

A0A0252 (Exp 2/2019)

A0A0253 (Exp 2/2019)

A0A0292 (Exp 2/2019)

A0A0293 (Exp 2/2019)

A0A0361 (Exp 3/2019)

A0A0367 (Exp 3/2019)

A0A0390 (Exp 3/2019)

A0A0438 (Exp 4/2019)

A0A0445 (Exp 4/2019)

A0A0453 (Exp 4/2019)

A0A0459 (Exp 4/2019)

A0A0547 (Exp 5/2019)

A0A0551 (Exp 5/2019)

A0A0554 (Exp 5/2019)

A0A0630 (Exp 5/2019)

A0A0631 (Exp 5/2019)

A0A0637 (Exp 5/2019)

A0A0638 (Exp 5/2019)

A0A0777 (Exp 7/2019)

A0A0915 (Exp 8/2019)

A0A0919 (Exp 8/2019)

A0A0924 (Exp 8/2019)

A0A0930 (Exp 8/2019)

A0A1094 (Exp 11/2019)

A0A1097 (Exp 11/2019)

A0A1110 (Exp 11/2019)

Date Ranges: Exp 10/2018, Exp 11/2018, Exp 12/2018, Exp 1/2019, Exp 2/2019, Exp 3/2019, Exp 4/2019, Exp 5/2019, Exp 7/2019, Exp 8/2019, Exp 11/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81353

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospitals; Pharmacies

Manufactured In: United States, India

Units Affected: 402,165 vials

Distributed To: Nationwide

Agency Last Updated: November 7, 2018

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication vials for Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL) in 5 mL single-use glass vials with NDC 36000-033-10.

Verify if your product matches one of the affected lot numbers and expiration dates: 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).

If you have an affected vial, contact your healthcare provider or pharmacist immediately to discuss alternative treatments and ensure you do not use the out-of-specification medication.

Return any unused vials to the pharmacy or place of purchase to receive a refund.

Contact Baxter Healthcare Corporation at their headquarters at 1-888-229-0001 for more information regarding this recall.

For additional consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL)

Model:

NDC: 36000-033-10

Lot Numbers:

A061267 (Exp 10/2018)

A061273 (Exp 10/2018)

A061392 (Exp 11/2018)

A061395 (Exp 11/2018)

A061398 (Exp 11/2018)

A061403 (Exp 11/2018)

A061407 (Exp 11/2018)

A0A0070 (Exp 12/2018)

A0A0073 (Exp 12/2018)

A0A0079 (Exp 12/2018)

A0A0081 (Exp 12/2018)

A0A0083 (Exp 12/2018)

A0A0119 (Exp 1/2019)

A0A0124 (Exp 1/2019)

A0A0125 (Exp 1/2019)

A0A0133 (Exp 1/2019)

A0A0141 (Exp 1/2019)

A0A0145 (Exp 1/2019)

A0A0152 (Exp 1/2019)

A0A0247 (Exp 2/2019)

A0A0252 (Exp 2/2019)

A0A0253 (Exp 2/2019)

A0A0292 (Exp 2/2019)

A0A0293 (Exp 2/2019)

A0A0361 (Exp 3/2019)

A0A0367 (Exp 3/2019)

A0A0390 (Exp 3/2019)

A0A0438 (Exp 4/2019)

A0A0445 (Exp 4/2019)

A0A0453 (Exp 4/2019)

A0A0459 (Exp 4/2019)

A0A0547 (Exp 5/2019)

A0A0551 (Exp 5/2019)

A0A0554 (Exp 5/2019)

A0A0630 (Exp 5/2019)

A0A0631 (Exp 5/2019)

A0A0637 (Exp 5/2019)

A0A0638 (Exp 5/2019)

A0A0777 (Exp 7/2019)

A0A0915 (Exp 8/2019)

A0A0919 (Exp 8/2019)

A0A0924 (Exp 8/2019)

A0A0930 (Exp 8/2019)

A0A1094 (Exp 11/2019)

A0A1097 (Exp 11/2019)

A0A1110 (Exp 11/2019)

Date Ranges: Exp 10/2018, Exp 11/2018, Exp 12/2018, Exp 1/2019, Exp 2/2019, Exp 3/2019, Exp 4/2019, Exp 5/2019, Exp 7/2019, Exp 8/2019, Exp 11/2019