traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro…
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Yes — there is an active recall. 326 ongoing FDA recalls mention Chloride (1,994 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chloride. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason Failed Dissolution Specifications
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Reason Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability…
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Reason Superpotent Drug: Due to overfilling of drug powder
Reason Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label…
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product…
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the…
Reason Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Reason Subpotent Drug
Reason Presence of Foreign Tablets/Capsules
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
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