Multi-event October 2020 FDA Recall Lansoprazole by Zydus Pharmaceuticals
usa Inc
This Multi-event Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on October 27, 2020 for the product Lansoprazole. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0074-2021
Failed Dissolution Specification
10-27-2020
11-11-2020
6,840 units
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.
Zydus Pharmaceuticals (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.
Distributed Nationwide in the USA
12-20-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77
Batch or Lot Expiration Information
Lot# M005681, EXP 3/2022
Affected Packages Involved in this Recall
Recall Number: D-0075-2021
Failed Dissolution Specification
10-27-2020
11-11-2020
7,908 units
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.
Zydus Pharmaceuticals (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.
Distributed Nationwide in the USA
12-20-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77
Batch or Lot Expiration Information
Lot# M005682, EXP 3/2022
