Reported Jan 12, 2022 · Terminated

PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated…

ULTRAtab Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ULTRAtab Laboratories, Inc. · 50 Toc Dr · Highland, NY · 12528-1506

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 codes and dates: 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
Amount recalled: 14 bulk lots (approximately 1,987,951 tablets each)

CGMP Deviations: failed stability results, inadequate laboratory investigations,

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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