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Recall Observatory FDA recall evidence

Drug product

HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

D-0195-2021

December 17, 2020

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 86990
Status
Terminated
Classification
Class II
Quantity
3,092 syringes
Official record key
drug-enforcement:D-0195-2021

Official wording

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

Code information: a) Lot # 1220023171, BUD 1/26/2021; 1220023282, BUD 2/1/2021; 1220023446, BUD 2/7/2021; 1220023532, BUD 2/8/2021; 1220023650, BUD 2/11/2021 & 1220023727, BUD 2/14/2021. b) Lot # 1220023241, BUD 1/25/2021; 1220023313, BUD 2/1/2021 & 1220023442, BUD 2/7/2021.

Distribution pattern: Product was distributed to hospitals nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility