Why it was 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).
Product description
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
Lot numbers, UPCs & expiration codes
L503092, Exp 04/2016
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1471-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 2, 2016
- FDA report date
- Aug 31, 2016
- Quantity
- 672 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-1471-2016, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74902
- Address
- 400 Interpace Pkwy
- Code information
- L503092, Exp 04/2016
- Postal code
- 07054-1120
- Report date
- Aug 31, 2016
- Product type
- Drugs
- Recall number
- D-1471-2016
- Classification
- Class III
- Recalling firm
- Actavis Inc
- Product quantity
- 672 bottles
- Termination date
- Feb 8, 2017
- Reason for recall
- 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 2, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2016