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Recall Observatory FDA recall evidence

Drug product

HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022

D-0407-2024

November 09, 2023

Class II

Product summary

Firm
SCA Pharmaceuticals, LLC
Event
Event 93456
Status
Terminated
Classification
Class II
Quantity
1,023 syringes
Official record key
drug-enforcement:D-0407-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot#: 1223048801 Exp 12/04/23; 1223049225 Exp 12/21/23; 1223049264 Exp 12/25/23; 1223049291 Exp 12/26/23; 1223049726 exp 01/11/24

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility