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Recall Observatory FDA recall evidence

Drug product

ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67

D-0963-2018

June 12, 2018

Class II

Product summary

Firm
Avella of Deer Valley, Inc. Store 38
Event
Event 80307
Status
Terminated
Classification
Class II
Quantity
10500 syringes
Official record key
drug-enforcement:D-0963-2018

Official wording

Reason: Lack of Assurance of Sterility: Potential leakage of bags.

Code information: Lot #: 3/5/18 6702 80567S, 3/5/18 2119 80567S, BUD 7/3/2018; 4/30/18 3701 80567S, BUD 8/28/2018; 5/10/18 3333 80567S, 5/10/18 2222 80567S, 5/10/18 1111 80567S, BUD 9/7/2018. .

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility