Reported Jul 18, 2012 · Terminated
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS,…
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals · 120 Vintage Dr NE · Huntsville, AL · 35811-8216
Is this the product you have?
- HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg
- for
QUALITEST PHARMACEUTICALSHUNTSVILLEAL 35811NDC 0603-7039-39UPC 3 0603-7039-39 7
- Lot codes and dates
Lot #: L072B11AExp 8/12L102C11AL103C11AExp 10/12L046D11AL082F11AL089F11AExp 11/12L148J11AL149J11AL150J11AExp 03/13and L151J11AExp 04/13
- Amount recalled
- 54,431 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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