Class II · Moderate risk Ongoing
PReye Vitamin See Antioxidant Preservative Free Eye Drops
Reason Lack of Assurance of Sterility
Clobetasol Propionate Cream USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
What was recalled
Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1496-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Gold recalls
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Class II · Moderate risk Ongoing
Deodorant: a) Axe
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Trinity Gold Nutrition
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class I · High risk Ongoing
Gold Hard Steel Plus Liquid
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
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