The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0596-2018·Announced 2018-03-21

Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Non-Sterility Concerns

Pfizer is recalling 53,600 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass vials.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

Pfizer Inc. is recalling 53,600 vials of Hydromorphone Hydrochloride Injection, USP CII, 10 mg/mL. The product is a high-potency prescription formulation manufactured for Teva Parenteral Medicines, Inc. The affected lots are #691853F (expiration 9/1/2018) and #700753F (expiration 10/1/2018). The recall was initiated due to confirmed customer complaints regarding glass product container vials that may be empty or cracked, which raises concerns about non-sterility.

The affected product was distributed nationwide in the USA. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death. The specific hazard involves the integrity of the glass vials, which could compromise the sterility of the medication.

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 product matches the recalled description, it should not be used. Patients should contact their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

Product
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
Brand
HYDROMORPHONE HYDROCHLORIDE
Manufacturer
Pfizer Inc.
Category
Drug — Injection
Hazard
Affected units
53,600

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 (4)

  • Lots # 691853F
  • EXP. 9/1/2018
  • 700753F
  • EXP. 10/1/2018.

UPCs (1)

  • 0307030110038

Distribution

Distributed nationwide across the United 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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