Recalls / Class II
Class IID-1494-2019
Product
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.
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recalling firm
- Firm
- Pharma-Natural Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 14500 Nw 60th Ave Bldg 7f, N/A, Miami Lakes, Florida 33014
Distribution
- Quantity
- 4981 roll on bottles
- Distribution pattern
- Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2019-06-21
- FDA classified
- 2019-07-23
- Posted by FDA
- 2019-07-31
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1494-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.