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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

RemedyRepack Inc.: Metoprolol Tartrate Injection Recalled for Failed pH Levels

Agency Publication Date: November 14, 2018
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Summary

RemedyRepack Inc. is recalling one vial of Metoprolol Tartrate Injection, USP 5mg/5mL, a prescription medication used to treat high blood pressure and chest pain. This recall was initiated after stability testing revealed that the medication's pH levels were outside of the required safety specifications. Only a single vial was distributed to a medical facility in Mayville, New York, but consumers who may have received this medication should be aware of the potential for reduced effectiveness or safety concerns.

Risk

The pH level of an injectable medication is critical for its stability and compatibility with the human body; levels that are too high can cause the drug to break down prematurely or potentially cause irritation at the injection site. No injuries or adverse incidents have been reported to date regarding this specific unit.

What You Should Do

  1. Check your medication records or packaging to see if you received Metoprolol Tartrate Injection, USP 5mg/5mL, manufactured by Claris Lifesciences Inc. and repackaged by RemedyRepack (NDC# 70518-0868-00).
  2. Verify if your medication matches either of the affected lot numbers: Lot #: A0A0253 with expiration date 02/2019, or Lot #: B0369427-112717 with expiration date 08/2019.
  3. Immediately contact your healthcare provider or pharmacist for guidance if you believe you have been administered or are in possession of this recalled vial.
  4. Return any unused product to the pharmacy or medical facility where it was obtained for a refund.
  5. Contact RemedyRepack Inc. at their Indiana, Pennsylvania location for further instructions regarding this recall.
  6. For additional 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

๐Ÿ’ฐFull Refund

Healthcare consultation and refund

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 5mg/5mL, vials
Model:
NDC# 70518-0868-00
Recall #: D-0245-2019
Lot Numbers:
A0A0253 (Exp. 02/2019)
B0369427-112717 (Exp. 08/2019)
Date Ranges: Expiration 02/2019, Expiration 08/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81554
Status: Resolved
Manufacturer: RemedyRepack Inc.
Sold By: Medical facility in Mayville, NY
Manufactured In: United States
Units Affected: 1 vial
Distributed To: New York

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 ยท 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.