All Entries in the "Dangerous Drugs" Category
PediaCare Children’s Products [Blacksmith Brand]: Recall of four products
The four products were manufactured at a plant cited by FDA for deficiencies in Good Manufacturing Practices. Posted 05/30/2010
GammaGard Liquid, Immune Globulin Intravenous (Human)
Market withdrawal due to an increased number of adverse event reports of allergic reactions associated with two lots.
Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change
Risk of overdosage or suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs.
Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors
Reports of consumers ingesting the gel rather than using it topically, applied to the skin.
Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility
Non-sterility of metronidazole injection administered via the intravenous route has the potential to result in infections, which could be fatal.
Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients
Patients to be informed of risk of severe injection site reactions.
Vita Breath Dietary Supplement
Consumers warned not to use product because it may contain hazardous levels of lead.
GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer
Possible increased risk of diabetes and certain cardiovascular diseases.
McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall
Certain over-the-counter Children’s and Infants’ liquid products may not meet required quality standards.
Atlas Operations, Inc.: Recall of Sexual Enhancement Products
[UPDATED 04/14/2010] Recall expanded to include additional products, sold as a dietary supplements, containing undeclared sulfoaildenafil, which may result in lowering of blood pressure to dangerous levels. Originally posted 12/15/2009
Propylthiouracil
[Updated 04/21/2010] FDA added a Boxed Warning to the label for propylthiouracil,to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients.
