Safety Alerts & Recalls

What does this mean?

This recall for Ultram ER Extended-Release Tablets, 100 mg 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 Ultram ER Extended-Release Tablets, 100 mg, you should follow up with your physician if you are concerned or are experiencing side effects..

Ortho-McNeil Pharmaceutical, Inc. Recalls Select Lots of Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg

Ortho-McNeil Pharmaceutical, Inc. is recalling several lots of Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg sold in 30 tablets per bottle and physician samples containing 4 tablets in a blister pack. The lot numbers listed below are being recalled because they failed the manufacturer routine tests that measure the rate the tablet released the active medicine. Tablets in these lot numbers may release the active ingredient at a slightly faster rate than required.

The following lot numbers are being recalled: Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg, 30 count bottle: Lot numbers P08H006, P08I008, P08I009, P08J012, P08J014, P08K017, P08K019, P09B017, P09B018, 09A006P, 09A007P, 09A008P, 09A013P, and 09A014P

Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg, Physician samples 4 count blister pack: Lot numbers 9AA3276 and 9AA3276P1

Ultram ER contains the active ingredient tramadol and is used to treat pain. Tramadol is also available under different names and formulations. This recall alert only applies to the select lots of Ultram ER Extended-Release Tablets, 100 mg. No other lots, strengths, brands, or formulations of tramadol were involved in this recall.

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

Source: FDA
Publication Date: 2010-07-21
Last Updated: 2010-07-23

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