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Recall Observatory FDA recall evidence

Drug product

PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011

D-0415-2024

November 09, 2023

Class II

Product summary

Firm
SCA Pharmaceuticals, LLC
Event
Event 93456
Status
Terminated
Classification
Class II
Quantity
7,198 syringes; expanded 1,289 syringes
Official record key
drug-enforcement:D-0415-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 1223045053 Exp 11/15/23; 1223046179 Exp 12/28/23; 1223047477 Exp 02/16/24; 1223047602 Exp 02/22/24; 1223047971 Exp 03/14/24; 1223048269 Exp 03/27/24 Expanded lot#: 1223048181, exp. date 03/22/2024

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility