CLASS II Drug recall · Reported 31 Jul 2019 · FDA Enforcement Report
Army Health With Curcumin (Menthol 3.00%) Pain Reliever recalled
Pharma-Natural is recalling Army Health With Curcumin (Menthol 3.00%) Pain Reliever Roll-On roll on, Manufactured, distributed nationwide in the US. The recall was initiated on 21 Jun 2019 and the FDA has classified it as Class II.
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-1494-2019
- FDA event ID
- 83190
- Recalling firm
- Pharma-Natural, Miami Lakes, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2019
- FDA classified
- 23 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 21 Jun 2019 | Recall initiated by company | |
| 23 Jul 2019 | Classified by FDA | +32 days |
| 31 Jul 2019 | 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
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
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
ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6.
Where it was distributed
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 83190This product is part of a recall event; the main page for the event is Gencontuss (Chlorpheniramine Maleate, 2mg recalled by Pharma-Natural.
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