Archive | May, 2010
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
Continue reading...Intravenous Medications Manufactured by Claris: Recall due to contamination of products
28. May 2010
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Products sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. Reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product.
Continue reading...Arrow Brand Medicated Oil and Embrocation: Consumer Warning, Product Considered Toxic
28. May 2010
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Product contains substances which are poisonous when ingested or applied to large areas of the body.
Continue reading...Hylenex recombinant (hyaluronidase human injection): Recall
26. May 2010
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Voluntary recall of all manufactured lots has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of vials during routine stability testing.
Continue reading...Orlistat (marketed as Alli and Xenical): Labeling Change
26. May 2010
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Revised labeling to include cases of severe liver injury.
Continue reading...Proton Pump Inhibitors (PPI): Class Labeling Change
25. May 2010
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Possible increased risk of fractures of the hip, wrist, and spine.
Continue reading...Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change
25. May 2010
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Risk of overdosage or suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs.
Continue reading...Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility
17. May 2010
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Non-sterility of metronidazole injection administered via the intravenous route has the potential to result in infections, which could be fatal.
Continue reading...Rotarix Vaccine: Update to Clinicians and Public Health Professionals
16. May 2010
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UPDATE 05/16/2010. FDA determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. Originally posted 03/22/2010
Continue reading...GE Healthcare Aisys and Avance Anesthesia Systems: Recall
13. May 2010
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Defective control board wiring harnesses can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
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28. May 2010
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