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Recall Observatory FDA recall evidence

Drug product

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.

D-0363-2023

February 24, 2023

Class III

Product summary

Firm
SCA Pharmaceuticals
Event
Event 91774
Status
Terminated
Classification
Class III
Quantity
2125 syringes
Official record key
drug-enforcement:D-0363-2023

Official wording

Reason: Subpotent Drug

Code information: Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023

Distribution pattern: Nationwide in the US.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent