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Recall Observatory FDA recall evidence

Drug product

Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

D-642-2013

March 20, 2013

Class II

Product summary

Firm
Clinical Specialties Compounding Pharmacy
Event
Event 64661
Status
Terminated
Classification
Class II
Quantity
35ml total
Official record key
drug-enforcement:D-642-2013

Official wording

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

Code information: Lot number CABCAFBB:81, Exp date: 5/4/2013; Lot number CABCCEAJ:85 Exp date: 3/23/2013 and Lot number CABDCFAC:25 Exp date: 8/24/2013.

Distribution pattern: FL, GA and SC.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility