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
Reported: August 31, 2016 Initiated: August 2, 2016 #D-1472-2016
Product Description
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
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).
Details
- Recalling Firm
- Actavis Inc
- Units Affected
- 2543 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Actavis Inc. Units affected: 2543 bottles.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 31, 2016. Severity: Low. Recall number: D-1472-2016.
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