The Recall Desk
SevereFDA (Drugs)·D-1487-2019·Announced 2019-07-24

Pfizer Recalls Milrinone Lactate Injection Bags Due to Sterility Concerns

Pfizer is recalling specific lots of Milrinone Lactate Injection bags because they may leak, compromising sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Pfizer Inc. is recalling 280,340 bags of Milrinone Lactate Injection 200 mcg (0.2 mg)/mL in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bags. The recall is due to a lack of assurance of sterility, as the bags have the potential to leak.

The affected product is identified by NDC 0409-2776-23 and includes specific lot numbers with expiration dates ranging from January 2020 to August 2020. The product was distributed in the United States, Puerto Rico, and Guam.

Healthcare providers and patients should stop using the affected lots and contact Pfizer or their local FDA office for further instructions.

The recalled product

Product
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.
Manufacturer
Pfizer Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
280,340

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Lot #s: 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.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Pfizer Inc.

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Same hazard · sterility

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