May 30, 2018DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Mo
Hazard: GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
May 30, 2018DrugsFDA
AMA Wholesale recalls Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
May 23, 2018DrugsFDA
AuroMedics Pharma LLC recalls Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only
Hazard: Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
May 23, 2018DrugsFDA
Apotex Inc. recalls Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Ho
Hazard: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
May 23, 2018DrugsFDA
Apotex Inc. recalls Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by:
Hazard: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
May 23, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV
Hazard: cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
May 23, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV
Hazard: cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
May 23, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart
Hazard: Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
May 23, 2018DrugsFDA
Perrigo New York recalls Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrig
Hazard: Failed Stability Specifications
May 23, 2018DrugsFDA
L. Perrigo Company recalls Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46);
Hazard: Defective delivery system
May 23, 2018DrugsFDA
Pharmalucence, Inc. recalls Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC
Hazard: Failed Stability Specifications
May 23, 2018DrugsFDA
Milbar Laboratories, Inc. recalls MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN
Hazard: GMP Deviations
May 23, 2018DrugsFDA
Milbar Laboratories, Inc. recalls Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX
Hazard: GMP Deviations
May 23, 2018DrugsFDA
Milbar Laboratories, Inc. recalls Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by
Hazard: GMP Deviations
May 23, 2018DrugsFDA
Milbar Laboratories, Inc. recalls B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Hazard: Microbial Contamination of Non-sterile Product
May 23, 2018DrugsFDA
Aidarex Pharmaceuticals LLC recalls Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
Hazard: Presence of Foreign Tablets/Capsules
May 23, 2018DrugsFDA
Prescript Pharmaceuticals, Inc. recalls Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckr
Hazard: Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
May 23, 2018DrugsFDA
Prescript Pharmaceuticals, Inc. recalls Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 1913
Hazard: Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
May 23, 2018DrugsFDA
Prescript Pharmaceuticals, Inc. recalls Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmac
Hazard: Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
May 23, 2018DrugsFDA
Prescript Pharmaceuticals, Inc. recalls Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo
Hazard: Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
May 23, 2018DrugsFDA
Prescript Pharmaceuticals, Inc. recalls Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: La
Hazard: Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
May 23, 2018DrugsFDA
Boiron Inc. recalls Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Hazard: Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
May 23, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc
Hazard: Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
May 16, 2018DrugsFDA
AuroMedics Pharma LLC recalls Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured
Hazard: Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
May 16, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per
Hazard: Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
May 16, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per bo
Hazard: Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
May 16, 2018DrugsFDA
Septodont Inc. recalls OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx on
Hazard: Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
May 16, 2018DrugsFDA
Coast Quality Pharmacy LLC recalls Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin
Hazard: Lack of Assurance of Sterility
May 16, 2018DrugsFDA
Kroger Specialty Pharmacy, Inc. recalls Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Hazard: Lack of Processing Controls.
May 16, 2018DrugsFDA
Kroger Specialty Pharmacy, Inc. recalls Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Hazard: Lack of Processing Controls.