March 2019 FDA Recall Pravastatin Sodium by Glenmark Pharmaceuticals Inc., Usa
D-1120-2019 - Presence Of Foreign Tablet
This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on March 25, 2019 for the product Pravastatin Sodium. The FDA reported the reason for recall as presence of foreign tablet. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1120-2019
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
03-25-2019
04-17-2019
2076 500-count 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.
Glenmark Pharmaceuticals Inc., USA
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.
Nationwide in the USA
09-14-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Batch or Lot Expiration Information
Lot# Lot 17181491 Exp. Aug. 2021
