FDA-Drug2022-01-12Class II
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
ULTRAtab Laboratories, Inc.
Hazard
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Sold states
Product was distributed to one customer who may have further distributed the product.
Affected count
14 bulk lots (approximately 1,987,951 tablets each)
Manufactured in
50 Toc Dr, N/A, Highland, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0327-2022Don't want to check this manually?
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