Product contains undeclared milk.
All Recalls
95,114 total recalls in our database
This recall has been initiated due to detection of glyphosate residues above tolerance.
cGMP deviations: due to shipment of rejected units.
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
SUN PHARMACEUTICAL INDUSTRIES
Presence of Foreign Substance: Metal embedded in a tablet.
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Sagent Pharmaceuticals
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
New Vitalis Pharmacy LLC
Lack of Assurance of Sterility
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
Kramer Laboratories
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Defective Delivery System
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Hamilton Medical
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched