Acetasol HC recall: Impurity Out of Spec
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road…
Why was Acetasol HC recalled?
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
L503092, Exp 04/2016
- Product
- Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road…
- Recalling firm
- Actavis Inc
- Quantity
- 672 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- August 31, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)