Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
FDA Drug Recalls
84 recalls · Class III, newest first
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Bracco Diagnostics multihance
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Class III · Low risk
Magnesium Sulfate in Water for Injection
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Class III · Low risk
DermaZinc Spray
Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.
Class III · Low risk
Balnetar Therapeutic Tar Bath
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Class III · Low risk
Ciprofloxacin Tablets
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.