Key Takeaway

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# 62 by ULTRAtab Laboratories, Inc. was recalled on November 29, 2021. The hazard: CGMP Deviations: failed stability results, inadequate laboratory investigations,

FDA Drug Class II Terminated

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# 62

Recalled: November 29, 2021 ~14 bulk lots (approximately 1,987,951 tablets each) units affected 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

Hazard / Reason

CGMP Deviations: failed stability results, inadequate laboratory investigations,

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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# 62

Drugs

Company Information

ULTRAtab Laboratories, Inc.

Highland, NY, United States

View all 34 recalls by ULTRAtab Laboratories, Inc. →

Distribution

Product was distributed to one customer who may have further distributed the product.

Related Recalls

FDA Drug Class II

APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00

January 26, 2022
FDA Drug Class II

Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00

January 26, 2022
FDA Drug Class II

Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00

January 26, 2022
FDA Drug Class II

Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00

January 26, 2022
FDA Drug Class II

Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00

January 26, 2022
FDA Drug Class II

APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00

January 26, 2022

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.