The Recall Desk
SevereFDA (Drugs)·D-1168-2017·Announced 2017-09-27

Pfizer Recalls Levophed Injection Due to Sterility Assurance Concerns

Pfizer is recalling specific lots of Levophed (norepinephrine bitartrate) injection because a damaged sterilizing filter may have compromised 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from a lack of sterility assurance in an intravenous drug.

Plain-English summary

Pfizer Inc. is recalling 98,050 vials of Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL. The recall affects single-dose fliptop vials manufactured by Hospira, Inc. The affected lots are 753003A (Exp 9/18), 762153A, 760803A, and 761053A (Exp 10/18).

The recall was initiated due to a lack of sterility assurance. This issue resulted from the use of a damaged sterilizing filter for nitrogen during the manufacturing process. The product is distributed nationwide in the United States, including Puerto Rico, and in Singapore.

Healthcare providers and patients should stop using the affected lots immediately. Consumers should check their medication vials for the specific lot numbers and expiration dates listed above. If the medication matches the recalled lots, it should be returned to the pharmacy or healthcare provider for disposal or replacement.

The recalled product

Product
LEVOPHED (NOREPINEPHRINE BITARTRATE)
Brand
LEVOPHED
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Injection
Hazard
Affected units
98,050

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 #: 753003A
  • Exp 9/18
  • 762153A
  • 760803A
  • 761053A
  • Exp 10/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 brand · LEVOPHED

Same manufacturer · Pfizer Inc.

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Same hazard · sterility

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