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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 1441–1460 of 17,711 recalls

Class IIOngoing

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

April 17, 2024 · DrugView details →
Class IIOngoing

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

April 17, 2024 · DrugView details →
Class IIOngoing

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

April 17, 2024 · DrugView details →
Class IIOngoing

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

April 17, 2024 · DrugView details →
Class IIOngoing

Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00012 3

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

April 17, 2024 · DrugView details →
Class IIOngoing

ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.

ARG Laboratories, Inc.

Out of Specification for active ingredient

April 17, 2024 · DrugView details →
Class IIOngoing

ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7

ARG Laboratories, Inc.

Out of Specification for active ingredient

April 17, 2024 · DrugView details →
Class IIOngoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01.

Glenmark Pharmaceuticals Inc., USA

Failed Dissolution Specifications

April 17, 2024 · DrugView details →
Class IIOngoing

Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

April 17, 2024 · DrugView details →
Class IIOngoing

Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5

ARG Laboratories, Inc.

Out of Specification for active ingredient

April 17, 2024 · DrugView details →
Class IICompleted

Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01

Dercher Enterprises, Inc., DBA Gordon Laboratories

cGMP Deviations

April 12, 2024 · DrugView details →
Class IIOngoing

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08

Imprimis NJOF, LLC

Subpotent Drug

April 10, 2024 · DrugView details →
Class IIIOngoing

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01

Imprimis NJOF, LLC

Out of specification for assay

April 10, 2024 · DrugView details →
Class IIIOngoing

Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →
Class IIIOngoing

Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →
Class IIIOngoing

Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →
Class IIIOngoing

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →
Class IOngoing

Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.

Dr. Reddy's Laboratories, Inc.

Sub-potent Drug; powder discoloration associated with decreased potency

April 8, 2024 · DrugView details →
Class IOngoing

Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.

Dr. Reddy's Laboratories, Inc.

Sub-potent Drug; powder discoloration associated with decreased potency

April 8, 2024 · DrugView details →
Class IIITerminated

Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.

X-Gen Pharmaceuticals Inc.

Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.

April 2, 2024 · DrugView details →
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