PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated
Summary
The FDA issued a Class II for PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, by ULTRAtab Laboratories, Inc.. Reason: CGMP Deviations: failed stability results, inadequate laboratory investigations,.
Details
Source
Drug Recall
External ID
D-0327-2022
Action Date
2022-01-12
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: 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.
Quantity Affected: 14 bulk lots (approximately 1,987,951 tablets each)
Reason for Recall
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Distribution
Product was distributed to one customer who may have further distributed the product.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-29
Company
Highland, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 77 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
ULTRAtab Laboratories, Inc. has 43 FDA actions in our database, including 43 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ULTRAtab Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ULTRAtab Laboratories, Inc. have FDA actions?
ULTRAtab Laboratories, Inc. has 43 FDA actions in our database, including 43 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0327-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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