FDA recall D-1513-2020

Product

Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,

Reason for recall

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

Distribution

Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.

Key facts

Status

Terminated

Initiation date

2020-08-03

Report date

2020-08-26

Termination date

2021-03-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

New Paltz, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1513-2020