FDA Drug recall D-0070-2022
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161,…
- FDA Drug
- Class III
- terminated
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class III recall of PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161,… by Ultra Seal, citing failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0070-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-10-13 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ultra Seal |
| Distribution | US |
Product
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
Reason
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Identifiers
| code_info | Lot #: AK-9336, exp. date 21-Oct; K9406, AK-9407, exp. date 21-Dec; K-9860, exp. date 22-Oct; AK-1057, exp. date 23-Feb |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0070-2022%22
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