Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East…
Reason Cross Contamination with Other Products:(mycophenolate mofetil).
1,061 FDA recalls mention East. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of East.
Reason Cross Contamination with Other Products:(mycophenolate mofetil).
Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking…
Reason Failed Dissolution Specifications
Reason Presence of Foreign Tablets/Capsules
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Reason Failed Dissolution Specifications
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Reason cGMP deviations: Batch was released prior to approval.
Reason cGMP deviations: Batch was released prior to approval.
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Reason Failed Impurities/Degradation Specifications
Reason Product mixup: one foreign tablet found in product.
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Reason Subpotent Drug
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Reason Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Reason CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Reason Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Reason CGMP Deviations;
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