March 2016 FDA Recall Escitalopram by Lupin Limited
D-1516-201 - Labeling
This Class III drug recall was voluntarily initiated by Lupin Limited on March 24, 2016 for the product Escitalopram. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1516-201
Labeling: Incorrect or Missing Lot and/or Expiration Date
03-24-2016
09-28-2016
3,192 bottles (319,200 tablets)
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 Limited
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.
Nationwide
03-15-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
Batch or Lot Expiration Information
Lot# G510086; Exp. 11/17
