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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

Teva Pharmaceuticals USA: Penicillin V Potassium Recalled for Failing Impurity Specifications

Agency Publication Date: December 13, 2017
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Summary

Teva Pharmaceuticals is voluntarily recalling approximately 42,384 bottles of Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL. This prescription antibiotic is used to treat bacterial infections but was found to contain high levels of impurities and degradation products that do not meet required quality specifications. Because the medicine has begun to break down, it may not be as effective as intended or could contain unexpected chemical byproducts.

Risk

The presence of impurities and degradation products means the medication may have reduced potency, which can lead to ineffective treatment of infections. Additionally, high levels of out-of-specification impurities could potentially cause unexpected side effects or adverse reactions in patients.

What You Should Do

  1. Check your prescription bottle to see if it matches the affected product: Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL, 100 mL bottle (NDC 0093-4125-73).
  2. Look for lot number 35433115A with an expiration date of 01/18 printed on the label.
  3. If you have this specific lot, contact your healthcare provider or pharmacist immediately to discuss continuing your treatment and obtaining a replacement medication.
  4. Return any unused portion of the affected medication to your pharmacy for a refund and further instructions.
  5. Contact Teva Pharmaceuticals USA at their North Wales, PA office if you have additional questions regarding this recall.
  6. For further information or to report any adverse reactions, 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

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

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

Affected Products

Product: Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL (100 mL bottle)
Model:
NDC 0093-4125-73
Recall #: D-0108-2018
Lot Numbers:
35433115A (Exp 01/18)
Date Ranges: 01/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78641
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: Canada, United States
Units Affected: 42,384 bottles
Distributed To: Nationwide

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.