Class III · Low risk Ongoing
Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by…
Reason Cross contamination with other products.
FDA Drug Recalls
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Class III · Low risk Ongoing
Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC…
Reason Cross contamination with other products.
Class II · Moderate risk Ongoing
Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial…
Reason CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx…
Reason Failed Dissolution Specifications: results below specifications
Class II · Moderate risk Ongoing
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc…
Reason Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the…
Class II · Moderate risk Ongoing
Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370…
Reason Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Class III · Low risk Ongoing
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count…
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634…
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634…
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate…
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC…
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For…
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Class II · Moderate risk Ongoing
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only…
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class III · Low risk Ongoing
SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour…
Reason Sub-potent Drug
Class II · Moderate risk Ongoing
Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code…
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673…
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ…
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673…
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5…
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC…
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC…
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6…
Reason CGMP deviations
Class II · Moderate risk Ongoing
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL…
Reason This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class II · Moderate risk Ongoing
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL…
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.