Reported Feb 26, 2020 · Terminated
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count…
Teva Pharmaceuticals USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only
- Manufactured in Czech Republic forTeva Pharmaceuticals USA, Inc., North Wales, PA 19545
- Lot codes and dates
226 of 226 codes
Lot#: a) 100005876Exp 02/2020100008310100008311Exp 07/2020100008638100008639Exp 09/202010001176302/2021b) 100005418100005419100005420100005421100005877100005878Exp 01/2020100005879100005880100005881100005882100005883100005884100005885100005886100005887100005888100005889100005890100005891100005892100005893100005894100005895100005896100005897100005898100005899100005900100005901100005902100005903100006588100006718100006719100006720100006721Exp 02/2020100006722100006724100006725100006726100006727100006728100006729100006730100006731100006732100006733100006734
- Amount recalled
- 2,044,497 bottles
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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