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Recall Observatory FDA recall evidence

Drug product

Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass vials, with filter, in bag, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

D-0141-2015

August 27, 2014

Class II

Product summary

Firm
Martin Avenue Pharmacy, Inc.
Event
Event 69152
Status
Terminated
Classification
Class II
Quantity
7 kits
Official record key
drug-enforcement:D-0141-2015

Official wording

Reason: Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Code information: Lot Number: 07152014@50, Exp 10/13/2014; 07152014@54, Exp 10/13/2014; 07152014@55, Exp 10/13/2014; 07152014@56, Exp 10/13/2014; 07152014@48, Exp 10/13/2014; 07152014@49, Exp 10/13/2014; 08062014@53, Exp 11/4/2014

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility