18 FDA recalls mention Sulfamethoxazole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sulfamethoxazole.
Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Reason Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason cGMP deviations: Temperature abuse
Reason Presence of Foreign Substance- Potential of metal contamination.
Reason Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Reason Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Reason Failed Dissolution Specifications
Reason Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Reason Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Reason Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Reason Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Reason Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and…
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