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Recall Observatory FDA recall evidence

Drug product

Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

D-677-2013

March 20, 2013

Class II

Product summary

Firm
Clinical Specialties Compounding Pharmacy
Event
Event 64661
Status
Terminated
Classification
Class II
Quantity
13ml total
Official record key
drug-enforcement:D-677-2013

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Code information: Lot number CABCAIBA:36, Exp date: 4/6/2013; Lot number CABDDAAB:10, Exp date: 7/29/2013 and Lot number CABDAIAD:01 Exp date: 9/4/2013.

Distribution pattern: FL, GA and SC.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility