FDA-Drug2020-02-26Class III
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 for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
Teva Pharmaceuticals USA
Hazard
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.
Sold states
U.S.A. Nationwide
Affected count
2,044,497 bottles
Manufactured in
400 Interpace Pkwy, Parsippany, NJ, United States
Products
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 for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0851-2020Don't want to check this manually?
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