84 recalls · Class III, newest first
Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.
CGMP Deviations: Shipment of product not approved for release.
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Defective Container; damaged blister units
Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.
Subpotent; fluocinolone acetonide
Subpotent; fluocinolone acetonide
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.