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 Stat

FDA recall notice · announced August 19, 2020 · Taro Pharmaceuticals U.s.a

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Reason for recall

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

Notes

Distribution: Nationwide in the U.S.
Lot/code information: a) AB28353, Exp 12/31/2021; b) AB40178, Exp 12/31/2021
Quantity: 7632 tubes
Status: Terminated
Products in this recall event:
- 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. Bram (D-1496-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.