September 2019 FDA Recall Pioglitazone by Macleods Pharma Usa Inc
D-0140-2020 - Superpotent
This Class II drug recall was voluntarily initiated by Macleods Pharma Usa Inc on September 23, 2019 for the product Pioglitazone. The FDA reported the reason for recall as superpotent. The product was distributed in Product was shipped to 8 distributors who may have further distributed the product. and the recall is currently terminated.
Recall Number: D-0140-2020
Superpotent
09-23-2019
10-23-2019
31,968 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Macleods Pharma Usa 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was shipped to 8 distributors who may have further distributed the product.
02-23-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33342-054-07
Batch or Lot Expiration Information
Lot# BPF901A, exp. date 12/2021
