November 2021 FDA Recall Drug by Ultratab Laboratories, Inc.
D-0327-2022 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Ultratab Laboratories, Inc. on November 29, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to one customer who may have further distributed the product. and the recall is currently terminated.

Recall Number: D-0327-2022

Reason for Recall
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Initiated
11-29-2021
Reported
01-12-2022
Quantity
14 bulk lots (approximately 1,987,951 tablets each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89214
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.
ULTRAtab Laboratories, 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.
Product was distributed to one customer who may have further distributed the product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-24-2023
Product Description About Product Description
Full technical description of the product.
PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L

Batch or Lot Expiration Information

Lot# Bulk Lots: 18K070, exp. date Nov-21; 19A046, exp. date Jan-22; 19C073, exp. date Mar-22; 19E014, exp. date May-22; 19G039, exp. date Jul-22; 19K002, exp. date Nov-22; 20A013, exp. date Jan-23; 20B050, exp. date Feb-23; 20C011, exp. date Mar-23; 20C049, exp. date Mar-23; 20F071, exp. date Jun-23; 20F072, exp. date Jun-23; 20G033, exp. date Jul-23; 20G041, exp. date Jul-23.