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Recall Observatory FDA recall evidence

Drug product

HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

D-0196-2021

December 17, 2020

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 86990
Status
Terminated
Classification
Class II
Quantity
1,056 syringes
Official record key
drug-enforcement:D-0196-2021

Official wording

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Code information: a) Lot # 1220022964, BUD 1/19/2021; 1220023280, BUD 2/1/2021 & 1220023623, BUD 2/10/2021. b) Lot # 1220023347, BUD 2/17/2021.

Distribution pattern: Product was distributed to hospitals nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility