1,523 recalls · Class III, newest first
Reason Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Reason Labeling: Missing Label; The label on the immediate bottle is missing.
Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Reason Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Reason Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the…
Reason Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Reason Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Reason Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however…
Reason Subpotent Drug: Phenylephrine component is subpotent.
Reason Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an…
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of…
Reason Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Reason Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
Reason Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the…
Reason Labeling; Missing label; ampoules are missing the immediate container label
Reason Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Reason Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Reason Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Reason Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with…
Reason Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with…