The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1486-2019·Announced 2019-07-24

Pfizer Recalls Milrinone Lactate Injection Bags Due to Sterility Concerns

Pfizer is recalling 58,200 bags of Milrinone Lactate Injection in 5% Dextrose due to a lack of assurance of sterility and potential for bag leaks.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 58,200 bags of Milrinone Lactate Injection 200 mcg (0.2 mg)/mL in 5% Dextrose Injection 40 mg/200 mL. The product is identified by NDC 0409-2776-02 and is available in 200 mL bags. The recall covers specific lots: 86-615-KL (Exp. 1FEB2020), 87-701-KL (Exp. 1MAR2020), and 90-114-KL (Exp. 1JUN2020).

The recall was initiated due to a lack of assurance of sterility, as the bags have the potential to leak. This defect could compromise the sterility of the medication, which is a critical safety requirement for intravenous injections.

The affected product was distributed in the United States, Puerto Rico, and Guam. Healthcare providers and facilities should discontinue use of the recalled lots and contact Pfizer for further instructions or returns.

The recalled product

Product
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.
Manufacturer
Pfizer Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
58,200

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 (6)

  • Lot #s: 86-615-KL
  • Exp. 1FEB2020
  • 87-701-KL
  • Exp. 1MAR2020
  • 90-114-KL
  • Exp. 1JUN2020

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 →

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