The Recall Desk

FDA (Drugs) recall action 83190

Pharma-Natural Inc. recalled 16 products on 2019-07-31

The FDA (Drugs) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.

Products
16
Announced
2019-07-31
Critical
0
Units
59,878

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–16 of 16

  • SevereFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls Workvie Pain Roll-On for Manufacturing Violations

    Pharma-Natural Inc. is recalling Workvie Instant Pain Relieving Roll On due to current good manufacturing practice deviations, including lack of process and cleaning validation.

    Product
    Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls Lid O Creme Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling Lid O Creme topical analgesic cream because it was manufactured with current good manufacturing practice violations, including lack of process validation.

    Product
    Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Distributed by: Pharma Natural, Inc. Hialeah, FL 33016, NDC 63788-111-25.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls Army Health Pain Reliever Roll-On for CGMP Violations

    Pharma-Natural Inc. is recalling Army Health Pain Reliever Roll-On bottles due to manufacturing process violations. The product was distributed in Florida and Texas.

    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.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    FDA Recalls Oliver's Harvest CBD+Lidocaine Cream for Manufacturing Violations

    Pharma-Natural Inc. is recalling Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief Cream due to current good manufacturing practice violations, including lack of process and cleaning validation.

    Product
    Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls AbeeMed Cream Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling AbeeMed cream because it was manufactured with current good manufacturing practice violations, including a lack of process and cleaning validation.

    Product
    AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Lido E.R. Lidocaine Cream Recalled for Manufacturing Violations

    Pharma-Natural Inc. is recalling Lido E.R. Lidocaine Cream due to current good manufacturing practice violations, including lack of process and cleaning validation.

    Product
    Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., P.O. Box 2102, Vega Alta, PR 00692, NDC 63788-115-04.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls GENCONTUSS Cough Syrup Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling 3,000 bottles of GENCONTUSS cough syrup because it was manufactured with current good manufacturing practice violations.

    Product
    GENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls NEOGEN-D Cough Syrup Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling 2,052 bottles of NEOGEN-D cough syrup because the product was manufactured with current good manufacturing practice violations, including a lack of process and cleaning validation.

    Product
    NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls LidoAID Gel Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling LidoAID topical analgesic gel because it was manufactured with current good manufacturing practice violations, including a lack of process and cleaning validation.

    Product
    LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04.
    Category
    Distribution
    3 states
  • SevereFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls Double Tussin DM Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling 500 bottles of Double Tussin DM because the product was manufactured with current good manufacturing practice violations.

    Product
    DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls Tusslin Cough Syrup Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling Tusslin cough syrup because it was manufactured with current good manufacturing practice violations, including a lack of process validation.

    Product
    TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls Oliver's Harvest CBD+Capsaicin Cream for CGMP Violations

    Pharma-Natural Inc. is recalling 998 bottles of Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief Cream due to current good manufacturing practice violations.

    Product
    Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls Dayma Pain Gel for Manufacturing Violations

    Pharma-Natural Inc. is recalling 1,000 jars of Dayma SUPER FORTE XL10 Pain Relieving Topical Analgesic Gel due to current good manufacturing practice violations.

    Product
    Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    Pharma-Natural Recalls Army Health Pain Reliever Gel Due to CGMP Violations

    Pharma-Natural Inc. is recalling Army Health Pain Reliever Gel with Curcumin because it was manufactured with current good manufacturing practice violations.

    Product
    ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00461 1.
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2019-07-31

    FDA Recalls Dermanak Skin Cream Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling Dermanak Skin Fade Cream because it was manufactured with current good manufacturing practice violations.

    Product
    Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distributors, Inc., Miami, FL 33126, NDC 63788-108-02.
    Category
    Distribution
    3 states