Recalls / Class II
Class IID-1251-2019
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
- Affected lot / code info
- Lot: 01/14/19 0215 22110P Exp. 04/29/2019
Why it was recalled
Sub-potency
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, N/A, Houston, Texas 77054-2520
Distribution
- Quantity
- 560 bags
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2019-04-26
- FDA classified
- 2019-04-29
- Posted by FDA
- 2019-05-08
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1251-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.