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Recall Observatory FDA recall evidence

Drug product

Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1023-2019

March 13, 2019

Class II

Product summary

Firm
Advanced Pharma Inc.
Event
Event 82398
Status
Terminated
Classification
Class II
Quantity
22900 syringes
Official record key
drug-enforcement:D-1023-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: 10/24/18 3318 83061S Exp. 3/23/2019; 10/18/18 3354 83061S Exp. 3/17/2019; 10/23/2018 6050 83061S Exp. 3/22/2019; 10/23/18 8105 83061S Exp. 3/22/2019; 10/18/18 1961 83061S Exp. 3/17/2019; 10/18/18 2598 83061S Exp. 3/17/2019; 11/05/18 1184 83061S Exp. 4/4/2019; 10/22/18 0737 83061S Exp. 3/21/2019; 10/25/18 1198 83061S Exp. 3/24/2019; 11/06/18 4451 83061S Exp. 4/5/2019; 11/06/18 0108 83061S Exp. 4/5/2019; 10/22/18 1530 83061S Exp. 3/21/2019

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility