Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Reported: July 18, 2018 Initiated: July 5, 2018 #D-0909-2018
Product Description
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Reason for Recall
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 27,803 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.. Recalled by Teva Pharmaceuticals USA. Units affected: 27,803 bottles.
Why was this product recalled? ▼
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 18, 2018. Severity: Moderate. Recall number: D-0909-2018.
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