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Recall Observatory FDA recall evidence

Drug product

B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

D-1398-2014

May 12, 2014

Class II

Product summary

Firm
John W Hollis Inc
Event
Event 68557
Status
Terminated
Classification
Class II
Quantity
30 mL
Official record key
drug-enforcement:D-1398-2014

Official wording

Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Code information: Lot # 2095, Use by 8/17/14

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility