August 2021 FDA Recall Drug by Granules Usa, Inc.
D-0777-2021 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Granules Usa, Inc. on August 11, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in NY and the recall is currently terminated.

Recall Number: D-0777-2021

Reason for Recall
CGMP Deviations
Initiated
08-11-2021
Reported
09-08-2021
Quantity
11,450,000 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88475
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Granules USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2023
Product Description About Product Description
Full technical description of the product.
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36

Batch or Lot Expiration Information

Lot# 7620060a