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Recall Observatory FDA recall evidence

Drug 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

D-1251-2019

April 26, 2019

Class II

Product summary

Firm
Advanced Pharma Inc.
Event
Event 82718
Status
Terminated
Classification
Class II
Quantity
560 bags
Official record key
drug-enforcement:D-1251-2019

Official wording

Reason: Sub-potency

Code information: Lot: 01/14/19 0215 22110P Exp. 04/29/2019

Distribution pattern: Nationwide in the US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sub-potency