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.
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals is recalling Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottles distributed nationwide in the USA and Puerto Rico. The recall affects approximately 24,180 bottles across eight specific lots with expiration dates ranging from April 2019 to July 2020. The product is being recalled because testing found elevated levels of impurities that are oxidative degradation products of the active ingredient, meaning the medication failed to meet quality specifications for purity.
This recall expands a previous recall initiated in October 2018 involving the same issue. The record does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Nationwide in the USA and Puerto Rico Quantity: 24,180 bottles Lot/code info: Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov-19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791, Exp Jul-20
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.