Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Reported: September 4, 2013 Initiated: March 11, 2013 #D-918-2013
Product Description
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Reason for Recall
Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes
Details
- Recalling Firm
- Clinical Specialties Compounding Pharmacy
- Units Affected
- 2190 syringes
- Distribution
- FL, GA, IN, LA and SC.
- Location
- Augusta, GA
Frequently Asked Questions
What product was recalled? ▼
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA. Recalled by Clinical Specialties Compounding Pharmacy. Units affected: 2190 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 4, 2013. Severity: Moderate. Recall number: D-918-2013.
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