Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
Reported: October 31, 2018 Initiated: October 5, 2018 #D-0092-2019
Product Description
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Details
- Recalling Firm
- LUPIN SOMERSET
- Units Affected
- 2712 60-ml bottles
- Distribution
- Nationwide in the USA
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60. Recalled by LUPIN SOMERSET. Units affected: 2712 60-ml bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0092-2019.
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