Class III
Terminated
Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
- Company
- Actavis Inc
- Recall Initiated
- August 2, 2016
- Posted
- August 31, 2016
- Recall Number
- D-1472-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2543 bottles
- Firm Location
- Parsippany, NJ, United States
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).
Distribution
Nationwide and Puerto Rico
Lot / Code Info
L503092, Exp 04/2016
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