Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
Reported: January 30, 2019 Initiated: January 15, 2019 #D-0390-2019
Product Description
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
Reason for Recall
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Details
- Recalling Firm
- LUPIN SOMERSET
- Units Affected
- 24,180 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.. Recalled by LUPIN SOMERSET. Units affected: 24,180 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 30, 2019. Severity: Moderate. Recall number: D-0390-2019.
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