Prescription and over-the-counter medications
SCA Pharmaceuticals
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
SCA Pharmaceuticals
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Presence of Particulate Matter: Glass
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Superpotent Drug: An oversized tablet was found in a bottle.
Presence of Particulate Matter
Fresenius Kabi USA
Subpotent Drug
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
SCA Pharmaceuticals
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Dr. Reddy's Laboratories
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
Hospira Inc., A Pfizer Company
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Lupin Pharmaceuticals
Failed Impurities/Degradation Specifications; Impurity A