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 Number: D-0327-2022

Firm: ULTRAtab Laboratories, Inc.

Classification: Class II

Status: Terminated

Report Date: 20220112

Initiation Date: 20211129

Termination Date: 20230224

CGMP Deviations: failed stability results, inadequate laboratory investigations,

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