Gentamicin buffered 36.4 mg/ml recall: Sterility Concern
Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Why was Gentamicin buffered 36.4 mg/ml recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Recalling firm
- Clinical Specialties Compounding Pharmacy
- Quantity
- 35ml total
- Distribution
- FL, GA and SC.
- Recall date
- July 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)