Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
16 FDA recalls mention Olmesartan. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Olmesartan.
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Failed Dissolution Specifications: low dissolution results
Reason cGMP deviations
Reason Presence of Foreign Tablet/Capsule
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval…
Reason Failed dissolution specifications
Reason Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream…
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
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