Class I - Dangerous
Failed impurities/degradation specifications: Out of specification for unknown impurities.
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Lupin Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class I - Dangerous
Presence of foreign substance
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Aurolife Pharma
Class I - Dangerous
Failed Impurities/Degradation Specifications
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09
Lupin Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class I - Dangerous
Underfilled units.
Class I - Dangerous
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Class I - Dangerous
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I - Dangerous
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Class I - Dangerous
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class I - Dangerous
Lack of sterility assurance: Bags have the potential to leak.
Class I - Dangerous
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Class I - Dangerous
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01
Heritage Pharmaceuticals
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Failed dissolution specifications
Class I - Dangerous
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Acella Pharmaceuticals
Class I - Dangerous
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Acella Pharmaceuticals
Class I - Dangerous
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.