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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Inc.: Milrinone Lactate Injection Recalled for Potential Leaks and Sterility Concerns

Agency Publication Date: July 12, 2019
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Summary

Pfizer Inc. is recalling 338,540 bags of Milrinone Lactate Injection 200 mcg/mL (0.2 mg/mL) in 5% Dextrose, including both 100 mL and 200 mL sizes. These Hospira brand products are being recalled because the bags have the potential to leak, which means the sterility of the medication cannot be guaranteed. This issue was discovered after the firm initiated a voluntary notification via letter to affected customers.

Risk

A leaking IV bag compromises the sterile barrier of the medication, which can lead to contamination. Administering a non-sterile injectable drug directly into the bloodstream poses a significant risk of serious infection or other life-threatening complications.

What You Should Do

  1. Check your supply for Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 200 mL bags (NDC 0409-2776-02) with lot numbers 86-615-KL (Exp. 1FEB2020), 87-701-KL (Exp. 1MAR2020), or 90-114-KL (Exp. 1JUN2020).
  2. Check your supply for Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 100 mL bags (NDC 0409-2776-23) with lot numbers 85-516-KL, 85-517-KL (Exp. 1JAN2020), 86-601-KL, 86-603-KL, 86-618-KL (Exp. 1FEB2020), 87-707-KL (Exp. 1MAR2020), 91-205-KL (Exp. 1JUL2020), or 92-306-KL (Exp. 1AUG2020).
  3. Immediately stop using the affected product if you identify any of these lot numbers in your inventory.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you have been administered this medication or have questions regarding your treatment.
  5. Return any unused product to the place of purchase or your pharmacy for a refund and contact Pfizer/Hospira for further instructions on returning the defective units.
  6. For additional information or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection (200 mL bag)
Model:
NDC 0409-2776-02
UPC Codes:
00304092776028
Lot Numbers:
86-615-KL (Exp. 1FEB2020)
87-701-KL (Exp. 1MAR2020)
90-114-KL (Exp. 1JUN2020)
Product: Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection (100 mL bag)
Model:
NDC 0409-2776-23
UPC Codes:
00304092776233
Lot Numbers:
85-516-KL
85-517-KL (Exp. 1JAN2020)
86-601-KL
86-603-KL
86-618-KL (Exp. 1FEB2020)
87-707-KL (Exp. 1MAR2020)
91-205-KL (Exp. 1JUL2020)
92-306-KL (Exp. 1AUG2020)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83267
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Hospitals; Pharmacies
Manufactured In: United States
Units Affected: 2 products (58200 bags; 280340 bags)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.