Class II · Moderate risk Ongoing
Clindamycin Palmitate Hydrochloride for Oral Solution
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Is Clindamycin recalled?
Yes — there is an active recall. 8 ongoing FDA recalls mention Clindamycin (45 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Clindamycin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class III · Low risk Ongoing
Clindamycin Phosphate USP
Reason Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class II · Moderate risk Ongoing
Clindamycin HCl Capsule
Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk Ongoing
Clindamycin Hydrochloride Capsules
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Clindamycin HCl
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Clindamycin Hydrochloride Capsules
Reason CGMP Deviations
Class III · Low risk Ongoing
Clindamycin Phosphate Topical Solution USP
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class III · Low risk Ongoing
Clindamycin Phosphate
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class II · Moderate risk Terminated
Cabtreo
Reason CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Class III · Low risk Terminated
Clindamycin Phosphate Topical Solution USP
Reason Defective Container: slow leakage under the cap
Class II · Moderate risk Terminated
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Clindamycin and Benzoyl Peroxide Gel
Reason Superpotent Drug
Class II · Moderate risk Terminated
Clindamycin Hydrochloride Capsules
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Clindamycin 900 mg in NS 50 mL bag
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Cleocin Phosphate
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Cleocin Phosphate
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Cleocin Phosphate
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Clindamycin Phosphate Topical Solution USP
Reason Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Class II · Moderate risk Terminated
Clindamycin 300 mg capsules
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 manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk Terminated
Clindamycin 150 mg capsules
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 manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk Terminated
Clindamycin Phosphate USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
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