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Recall D-0327-2022

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

Recall D-0327-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0327-2022
Event ID89214
DistributionProduct was distributed to one customer who may have further distributed the product.
Quantity14 bulk lots (approximately 1,987,951 tablets each)
Recall ReasonCGMP Deviations: failed stability results, inadequate laboratory investigations,
Drug ClassificationClass II
Drug Code Info20220112
Recall Initiation Date20211129
Report Date20220112
Classification Date20220104
Address50 Toc Dr
Highland, NY 12528-1506
United States
Recalling FirmULTRAtab Laboratories, Inc.
Initial Notification Letter
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