45 FDA recalls mention Clindamycin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Clindamycin.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Reason cGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Reason CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment…
Reason Defective Container: slow leakage under the cap
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Superpotent Drug
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of sterility assurance.
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…
Reason Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Reason Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original…
Reason Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Lack of Assurance of Sterility
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