NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183
Reported: September 25, 2013 Initiated: August 23, 2013 #D-1054-2013
Product Description
NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183
Reason for Recall
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Details
- Recalling Firm
- Medaus, Inc.
- Units Affected
- 15,500 mL
- Distribution
- Nationwide
- Location
- Birmingham, AL
Frequently Asked Questions
What product was recalled? ▼
NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183. Recalled by Medaus, Inc.. Units affected: 15,500 mL.
Why was this product recalled? ▼
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 25, 2013. Severity: Moderate. Recall number: D-1054-2013.
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