Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834…
Reason Failed Dissolution Specifications
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 Failed Dissolution Specifications
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…
Reason Failed Impurities/Degradation Specifications
Reason Failed Dissolution Specifications
Reason Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Reason Subpotent drug
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before…
Reason CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before…
Reason Tablets/Capsules Imprinted with Wrong ID
Reason cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Reason Presence of Foreign Substance
Reason Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150…
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason Tablet/Capsules Imprinted with Wrong ID
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