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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 7281–7300 of 17,773 recalls

Class IITerminated

Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04

H J Harkins Company Inc dba Pharma Pac

Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

June 24, 2019 · DrugView details →

Class IITerminated

Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.

H J Harkins Company Inc dba Pharma Pac

Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

June 24, 2019 · DrugView details →

Class IITerminated

GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-660-16.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

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.

Pharma-Natural Inc.

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

June 21, 2019 · DrugView details →

Class IITerminated

Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44

Macleods Pharma Usa Inc

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

June 20, 2019 · DrugView details →

Class IITerminated

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10

Macleods Pharma Usa Inc

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

June 20, 2019 · DrugView details →

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