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:
http://www.iguard.org/r/058JiD8999Cs
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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..