Qualitest Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities
Vintage Pharmaceuticals is recalling 54,431 bottles of Hydrocortisone and Acetic Acid Otic Solution because impurity levels exceeded specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals is recalling 54,431 bottles of Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottle. The product is prescription-only and was distributed nationwide and in Puerto Rico.
The recall was initiated because the product failed to meet specifications for impurities at the 18-month room temperature time point. The affected lots include L072B11A, L102C11A, L103C11A, L046D11A, L082F11A, L089F11A, L148J11A, L149J11A, L150J11A, and L151J11A, with expiration dates ranging from August 2012 to April 2013.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance on alternative treatments. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- 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.
- Category
- Drug — Ophthalmic/Ear
- Hazard
- Affected units
- 54,431
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot #: L072B11A
- Exp 8/12
- L102C11A
- L103C11A
- Exp 10/12
- L046D11A
- L082F11A
- L089F11A
- Exp 11/12
- L148J11A
- L149J11A
- L150J11A
- Exp 03/13
- and L151J11A
- Exp 04/13
Distribution
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