The Recall Desk
SevereFDA (Drugs)·D-1167-2017·Announced 2017-09-27

Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns

Pfizer is recalling 115,370 vials of Hydromorphone Hydrochloride Injection because a damaged sterilizing filter may have compromised sterility assurance during manufacturing.

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 FDA classified this as a Class II recall involving a lack of sterility assurance in an injectable drug, which poses a risk of serious adverse health consequences such as infection, meeting the criteria for a Severe rating.

Plain-English summary

Pfizer Inc. is recalling 115,370 vials of Hydromorphone Hydrochloride Injection, USP, 2 mg/mL, 1mL Single-use vial. The product is packaged in cartons of 25 vials and is available by prescription only. The specific lot number is 760853A, and the NDC numbers are 0409-3365-11 (carton) and 0409-3365-01 (vial). The product was manufactured by Hospira, Inc., in Lake Forest, IL.

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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide in the United States, including Puerto Rico, as well as in Singapore. Healthcare providers and patients should check their inventory for this specific lot number and discontinue use if found. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments if they have been prescribed this medication.

The recalled product

Product
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
Brand
HYDROMORPHONE HYDROCHLORIDE
Manufacturer
Pfizer Inc.
Category
Drug — Injectable Prescription Drug
Hazard
Affected units
115,370

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 (1)

  • Lot: 760853A

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 · HYDROMORPHONE HYDROCHLORIDE

Same manufacturer · Pfizer Inc.

See all →

Same hazard · sterility assurance

See all →