CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals…
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
1,994 FDA recalls mention Chloride. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chloride.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…
Reason CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been…
Reason Presence of foreign substance
Reason Failed Impurities/Degradation Specifications
Reason Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Reason Subpotent Drug
Reason Presence of Particulate matter: Particulate matter identified as glass.
Reason Subpotent drug
Reason CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Reason CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Reason Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Reason Failed PH Specifications
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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