Safety Alerts & Recalls
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Latest Alerts
Coloplast Manufacturing US Recalls Select Lots of Critic-Aid Skin Paste 2.5 oz/71g
Colorplast Manufacturing US has recalled select lots of Critic-Aid Skin Paste 2.5 oz/71g. Lot numbers 2441567 and 2461319 are being recalled because these lots failed the routine stability tests performed by the manufacturer.
Critic-Aid Skin Paste is commonly used in the treatment of skin irritation. This recall alert only applies to the select lots of Critic-Aid Skin Paste. No other Critic-Aid Skin Paste products were involved in this recall.
To view the FDA notice about this recall, please visit:
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm255019.htm
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Recall on All ETHEX Brand PhenaVent
The ETHEX Corporation, a subsidiary of KV Pharmaceutical, has recalled all lots of ETHEX brand PhenaVent which contain the active ingredients guaifenesin and phenylephrine. These recalled products may have been manufactured under conditions that did not meet the current manufacturing standards called Good Manufacturing Practices (cGMPs). Some ETHEX products have recently had specific lots recalled due to defects found, including oversized tablets. ETHEX is now recalling all of their products to ensure that no other defective products remain available to patients.
The ETHEX products and the NDC numbers involved in the recall are listed below. The NDC number is a product number that is sometimes listed on a prescription label.
PhenaVent Capsules (NDC 58177-078-19)
PhenaVent D Tablets (NDC 58177-444-04)
PhenaVent LA Capsules (NDC 58177-095-19)
PhenaVent PED Capsules (NDC 58177-079-04)
For more information, please visit:
http://www.ethex.com/news/pressRelease012809.aspx
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