12 FDA recalls mention Tramadol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tramadol.
Reason Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability…
Reason Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count…
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Reason Packaging defect: blister packaging inadequately sealed.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing…
Reason Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Labeling:Label Mixup; traMADol HCl Tablet, 25 mg (1/2 of 50 mg) may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC…
Reason Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of…
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