December 2020 FDA Recall Tacrolimus by Strides Pharma Inc.
D-0180-2021 - Failed Moisture Limits
This Class III drug recall was voluntarily initiated by Strides Pharma Inc. on December 22, 2020 for the product Tacrolimus. The FDA reported the reason for recall as failed moisture limits. The product was distributed in PA and the recall is currently terminated.
Recall Number: D-0180-2021
Failed Moisture Limits
12-22-2020
01-06-2021
960 bottles
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.
Strides Pharma 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.
PA
01-26-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
Batch or Lot Expiration Information
Lot# Lot 7242728A; June 2023
