Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
cGMP deviations: Batch was released prior to approval.
Class I - Dangerous
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Subpotent: Out of Specification for Assay Test at the 3-month time point.
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
Advanced Accelerator Applications USA
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
ALEMBIC PHARMACEUTICALS
Class I - Dangerous
Failed Impurities/Degradation Specifications
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Out of Specification result observed in content uniformity testing
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
B. Braun Medical
Class I - Dangerous
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0413-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility: Lack of validation data for sanitization cycles
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility: Lack of validation data for sanitization cycles
midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility: Lack of validation data for sanitization cycles
fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility: Lack of validation data for sanitization cycles
fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility: Lack of validation data for sanitization cycles
oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0427-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.