CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
All Recalls
95,064 total recalls in our database
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Westlab Pharmacy, Inc.
Incorrect Product Formulation
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
Upsher Smith Laboratories
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Presence of precipitate
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Upsher Smith Laboratories
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
Valeant Pharmaceuticals North America
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
Custom Healthcare Systems
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
APTIO 15000 REFRIGERATED STORAGE MODULE
Siemens Healthcare Diagnostics
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
Custom Healthcare Systems
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
APTIO RACK INPUT MODULE
Siemens Healthcare Diagnostics
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
Custom Healthcare Systems
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility