Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle recall — FDA D-0827-2020
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Overview of recall records associated with Ascend Laboratories, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 22, Class III: 8.
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Failed Dissolution Specifications
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Presence of Foreign Substance; metal shard found in tablet
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
This page summarizes recall records in which the official source identifies Ascend Laboratories, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.