Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Packaging defect: blister packaging inadequately sealed.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
Compare with the code on your package — it is the most precise check available.
Drug: Tramadol Category: Pain Relief & OTC Medication
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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.
Subpotent Drug
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Failed Dissolution Specifications
Defective container; inadequately sealed blister packaging.
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