Pfizer Recalls Hydromorphone Hydrochloride Injection Vials Due to Non-Sterility
Pfizer is recalling 29,680 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass containers.
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 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves non-sterility and physical defects in a high-potency injectable drug.
Plain-English summary
Pfizer Inc. is recalling 29,680 vials of Hydromorphone Hydrochloride Injection, USP CII, 10 mg/mL. The affected product is a high-potency formulation distributed nationwide in the USA. The specific lot number is 71330DD, with an expiration date of 11/1/2018.
The recall was initiated due to confirmed customer complaints regarding non-sterility. Specifically, reports indicated that the glass product container vials may be empty or cracked. This defect poses a risk to the sterility and integrity of the medication.
Consumers and healthcare providers should stop using the affected vials immediately. The product should be returned to the pharmacy or supplier for disposal or credit in accordance with standard recall procedures.
The recalled product
- Product
- HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
- Brand
- HYDROMORPHONE HYDROCHLORIDE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable
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 71330DD EXP. 11/1/2018.
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 →Related recalls
Same brand · HYDROMORPHONE HYDROCHLORIDE
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