Recall category
Finished prescription and over-the-counter drugs that patients can identify from packaging or pharmacy records.
Lack of assurance of Sterility:
Missing from associated official evidence: action.
Subpotent Drug
Missing from associated official evidence: action.
Presence of Foreign Substance
Missing from associated official evidence: action.
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Missing from associated official evidence: action.
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Missing from associated official evidence: action.
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Missing from associated official evidence: action.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Missing from associated official evidence: action.
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Missing from associated official evidence: action.
Non-Sterility: Due to presence of Aspergillus penicillioides.
Missing from associated official evidence: action.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Missing from associated official evidence: action.
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Missing from associated official evidence: action.
Subpotent Drug
Missing from associated official evidence: action.
Presence of Foreign Substance.
Missing from associated official evidence: action.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Missing from associated official evidence: action.
CGMP Deviations
Missing from associated official evidence: action.
Presence of foreign substance
Missing from associated official evidence: action.
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Missing from associated official evidence: action.
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Missing from associated official evidence: action.
sub potency
Missing from associated official evidence: action.
Lack of Assurance of Sterility
Missing from associated official evidence: action.
CGMP Deviations
Missing from associated official evidence: action.
Incorrect product formulation: bag did not contain copper and famotidine per label.
Missing from associated official evidence: action.
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Missing from associated official evidence: action.
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Missing from associated official evidence: action.
