Safety Alerts & Recalls

What does this mean?

This recall for Alclometasone Dipropionate Ointment USP, 0.05% from Glenmark Generics Inc. was issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. If you take Alclometasone Dipropionate Ointment USP, 0.05% and are concerned, you should speak to your doctor or other healthcare professional.

Glenmark Generics Inc. Recalls Several Lots of Alclometasone Dipropionate Ointment USP, 0.05%

Glenmark Generics Inc. has recalled several lots of Alclometasone Dipropionate Ointment USP, 0.05%. The following lot numbers are being recalled because samples from these lots did not pass the manufacturer's routine tests for impurities: 15 gm tube - 05902013, 05902016, 05902021, 05902274, 05902275, 05100597, 05100633, 05100634, 05100903, 05100904

45 gm tube - 05901619, 05902030, 05902031, 05102082, 05102265, 05102266, 05100564

60 gm tube - 05901617, 05902215, 05902216, 05902255, 05902263, 051002264, 05100562, 05100564, 05100569, 05100578, 05100579

Alclometasone dipropionate is used in the treatment of skin itching and swelling. Alclometasone dipropionate is also sold under the brand name Aclovate. No other lots, strengths, or brands of alclometasone dipropionate were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2011-03-05
Last Updated: 2011-03-06

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