Akorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations
Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection due to CGMP deviations. The firm went out of business and could not complete required stability testing.
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: FDA Class II drug recall with CGMP deviations and incomplete stability studies. No adverse events or injuries are reported. Per the rubric, theoretical hazards without reported illness or injury score at most 3 (High).
Plain-English summary
Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL). The product is supplied in 1 mL ampules, 5 mL ampules, and 50 mL vials. This is a prescription injectable opioid pain medication.
The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations. The manufacturer went out of business and could no longer continue the required stability studies for the product.
The recalled product was distributed nationwide in the USA and Puerto Rico. All lots are included in this recall.
The recalled product
- Product
- Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Hazard
- cgmp-deviation
- incomplete-stability-testing
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)
- All Lots
Distribution
Distributed nationwide across the United States.
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