January 2023 FDA Recall Clobetasol Propionate by Lupin Pharmaceuticals Inc.
D-0174-2023 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on January 20, 2023 for the product Clobetasol Propionate. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0174-2023
Subpotent Drug: Low assay result observed during long-term stability testing.
01-20-2023
02-01-2023
5720 tubes
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
01-16-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Batch or Lot Expiration Information
Lot# : K101033; Exp 6/2024
