CLASS III Drug recall · Reported 3 Nov 2021 · FDA Enforcement Report
Vica-Cet Back Pain Relief (Acetaminophen 250 mg/Aspirin recalled
Ultra Seal is recalling Vica-Cet Back Pain Relief (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets/pk, distributed nationwide in the US. The recall was initiated on 13 Oct 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0071-2022
- FDA event ID
- 88843
- Recalling firm
- Ultra Seal, New Paltz, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Oct 2021
- FDA classified
- 26 Oct 2021
- Reported
- 3 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 13 Oct 2021 | Recall initiated by company | |
| 26 Oct 2021 | Classified by FDA | +13 days |
| 3 Nov 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Vica-Cet Back Pain Relief (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets/pk recalled?
Yes. Ultra Seal recalled Vica-Cet Back Pain Relief (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets/pk on 13 Oct 2021. The recall is Class III and its status is Terminated. Recall number D-0071-2022.
Why was it recalled?
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Which lots are affected?
Lot #: AK-9455, exp. date 22-Jan; AK-1109, AK-1110, exp. date 23-Mar; K-9821, exp. date 22-Sep
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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