HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Reported: July 18, 2012 Initiated: July 6, 2012 #D-1411-2012
Product Description
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Reason for Recall
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Details
- Recalling Firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Units Affected
- 54,431 bottles
- Distribution
- Nationwide and Puerto Rico.
- Location
- Huntsville, AL
Frequently Asked Questions
What product was recalled? ▼
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.. Recalled by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals. Units affected: 54,431 bottles.
Why was this product recalled? ▼
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 18, 2012. Severity: Low. Recall number: D-1411-2012.
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