Hospira Recalls Hydromorphone Hydrochloride Injection Due to Broken Vials
Hospira Inc. is recalling 145,600 vials of Hydromorphone Hydrochloride Injection because customer complaints confirmed that some glass vials may be broken or cracked, compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Hospira Inc. is recalling 145,600 vials of Hydromorphone Hydrochloride Injection, USP, 10 mg/mL. The recall involves specific lots of 1 mL single-dose vials distributed nationwide. The affected products are packaged under NDC 0703-0110-01, NDC 0703-0110-03, NDC 0409-2634-01, and NDC 0409-2634-10.
The recall was initiated due to a lack of assurance of sterility. Confirmed customer complaints indicated that some glass product container vials may be broken or cracked. This defect poses a risk to the sterility of the medication.
Healthcare providers and patients should stop using the affected vials. The specific lot numbers involved are 260753F, 261403F, 290153F, 24-080-DD, and 25-475-DD. Users should check their inventory against these lot numbers and expiration dates (ranging from December 2014 to May 2015) to identify affected units.
The recalled product
- Product
- HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
- Brand
- HYDROMORPHONE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 145,600
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 (9)
- Lot #: a) 260753F
- 261403F
- Exp 1FEB2015
- 290153F
- Exp 1MAY2015
- b) 24-080-DD
- Exp 1DEC2014
- 25-475-DD
- Exp 1JAN2015
UPCs (1)
- 0307030110038
Distribution
Distributed nationwide across the United States.
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