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Recall Observatory FDA recall evidence

Drug product

Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU + Vitamin A Acetate 100 IU/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy

D-0275-2017

November 17, 2016

Class II

Product summary

Firm
Tri-Coast Pharmacy
Event
Event 75763
Status
Ongoing
Classification
Class II
Quantity
21 vials
Official record key
drug-enforcement:D-0275-2017

Official wording

Reason: Lack of Assurance of Sterility

Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07182016A (12/31/2016)

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility