December 2019 FDA Recall Ranitidine by Granules India Limited
D-0632-2020 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Granules India Limited on December 13, 2019 for the product Ranitidine. The FDA reported the reason for recall as cgmp deviations. The product was distributed in OR, NY, NJ and the recall is currently ongoing.
Recall Number: D-0632-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
12-13-2019
01-08-2020
23,090,000 tablets
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Granules India 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
OR, NY, NJ
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Batch or Lot Expiration Information
Lot# 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
