Advanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution
Advanced Pharma Inc. is voluntarily recalling 560 bags of compounded Hydromorphone 20 mg/100 mL Injectable Solution due to sub-potency. The product was distributed nationwide in the US.
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 due to sub-potency of a potent opioid medication. While no specific injuries are reported in the source, the risk of inadequate pain management or treatment failure for a high-risk drug places this in the High severity category per the rubric for risk-of-harm products.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling 560 bags of HYDROmorphone 20 mg/100 mL Injectable Solution. The product is a compounded drug, sterile single-use bag, with NDC 42852-221-10. The recall was initiated on April 26, 2019, and the agency classification is Class II.
The reason for the recall is sub-potency, meaning the product may not contain the full labeled amount of the active ingredient. The affected lot is identified as 01/14/19 0215 22110P with an expiration date of 04/29/2019. The product was distributed nationwide in the United States.
The recall status is Terminated as of October 30, 2019. Advanced Pharma Inc. notified customers via email, fax, letter, press release, telephone, and visit. Consumers and healthcare providers should check their inventory for this specific lot and contact the firm or their healthcare provider for further instructions.
The recalled product
- Product
- HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Opioid
- Affected units
- 560
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: 01/14/19 0215 22110P Exp. 04/29/2019
Distribution
Distributed nationwide across the United States.
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