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Recall Observatory FDA recall evidence

Drug product

Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1033-2019

March 13, 2019

Class II

Product summary

Firm
Advanced Pharma Inc.
Event
Event 82398
Status
Terminated
Classification
Class II
Quantity
2325 syringes
Official record key
drug-enforcement:D-1033-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: 10/19/18 2117 24163M Exp. 3/18/2019; 11/5/18 1363 24163M Exp. 4/4/2019; 11/5/18 1511 24163M Exp. 4/4/2019; 10/19/18 2061 24163M Exp. 3/18/2019; 10/23/18 1963 14163M Exp. 3/22/2019; 10/19/18 1441 24163M Exp. 3/18/2019

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility