Recalls / Class III

Class IIID-0076-2022

Product

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)

Affected lot / code info

Lot #: K-9335, AK-9419, exp. date 21-Oct; AK-9369, exp. date 21- Nov; AK-9403, exp. date 21-Dec; AK-9452, K-9455, 9455, exp. date 22-Jan; AK-9586, exp. date 22-Feb; AK-9525, AK-9526, AK-9639, exp. date 22-Mar; AK-9568, AK-9569, AK-9567, AK-9692, exp. date 22-Apr; AK-9615, exp. date 22-May; AK-9666, exp. date 22-Jun; AK-9714, K-9714, AK-9718, K-9718, 9718, exp. date 22-Jul, AK-9719, exp. date 22-Jul; AK-9771, AK-9765, AK-9769, exp. date 22-Aug; AK-9822, AK-9818, exp. date 22-Sep; AK-9860, exp. date 22-Oct; AK-9957, exp. date 22-Dec; AK-1011, K-1014, 1014, AK-9489, exp. date 23-Jan; 1055, K-1057, 1057, AK-1058, exp. date 23-Feb; AK-1108, AK-1113, K-1199, AK-1199, exp. date 23-May; AK-1240, 1240, exp. date 23-Jun; AK-9335, exp. date 10/21; AK-9406, exp. date 21-Dec; AK-1278, exp. date 23-Jul; K-1240, exp. date 23-Jun

Why it was recalled

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Recalling firm

Firm

Ultra Seal Corporation

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

521 Main St, N/A, New Paltz, New York 12561-1609

Distribution

Quantity

42,394,018 tablets

Distribution pattern

Nationwide in the USA.

Timeline

Recall initiated

2021-10-13

FDA classified

2021-10-26

Posted by FDA

2021-11-03

Terminated

2022-03-28

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0076-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.