Lincare Recalls Hydromorphone IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling specific lots of compounded Hydromorphone HCl IV bags because the sterility of the product is not assured.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious temporary or medically reversible health consequences.
Plain-English summary
Lincare, Inc. is recalling specific lots of compounded Hydromorphone HCl IV bags. The product is identified as Hydromorphone 1000 mg / NS 500 mL, 1 500 mL Bag, Rx Only. These products were compounded by United Medical IV Center in Little Rock, Arkansas.
The recall was initiated because the sterility of the product is not assured. The specific lot was compounded on May 29, 2015, and has a discard after date of June 26, 2015.
The affected products were distributed in the United States, including Arkansas. Patients who have received this specific product should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
- Manufacturer
- Lincare, Inc.
- Category
- Drug — IV Compounded
- Hazard
- Affected units
- 1
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 (2)
- Compounded on 05/29/15
- Discard After: 06/26/15
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 54 recalled by Lincare, 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.
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