Home / Recalls / Pharma-Natural Inc. / D-1494-2019

D-1494-2019 Class II Terminated

Recalled by Pharma-Natural Inc. — Miami Lakes, FL

Recall Details

Product Type
Drugs
Report Date
July 31, 2019
Initiation Date
June 21, 2019
Termination Date
October 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4981 roll on bottles

Product Description

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.

Reason for Recall

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Distribution Pattern

Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

Code Information

All lots remaining within expiry.

Other recalls by Pharma-Natural Inc.

  • F-1615-2023 Class III — Pharma Natural, Biotin 5000 mcg, Maximum Strength, Dietary Supplement, 30 Tablet (August 15, 2023)
  • D-1502-2019 Class II — Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (7 (June 21, 2019)
  • D-1507-2019 Class II — Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), (June 21, 2019)
  • D-1492-2019 Class II — Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analges (June 21, 2019)
  • D-1503-2019 Class II — Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Rel (June 21, 2019)
  • D-1496-2019 Class II — ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufac (June 21, 2019)
  • D-1501-2019 Class II — Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g (June 21, 2019)
  • D-1506-2019 Class II — NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7 (June 21, 2019)
  • D-1499-2019 Class II — LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 O (June 21, 2019)
  • D-1495-2019 Class II — Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Ana (June 21, 2019)