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Recall Observatory FDA recall evidence

Drug product

Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

D-0441-2019

December 17, 2018

Class II

Product summary

Firm
Promise Pharmacy, LLC
Event
Event 81810
Status
Terminated
Classification
Class II
Quantity
158 10 ml vials
Official record key
drug-enforcement:D-0441-2019

Official wording

Reason: Lack of sterility assurance.

Code information: Lot: 10022018@6 BUD: 12/31/2018

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility