Class III · Low risk Terminated
Aspirin DR Enteric Coated Tablets
Reason Failed Dissolution Specification; at the 12 month time interval.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Velivet
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk Terminated
Kariva
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk Terminated
Mircette
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk Terminated
Apri
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk Terminated
DENBLAN Anticavity Fluoride Toothpaste
Reason Stability Data Does Not Support Expiry
Class III · Low risk Terminated
Aplenzin¿
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Aplenzin¿
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Aplenzin¿
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Foradil Aerolizer
Reason Failed Stability Specification; out of specification result for particle size distribution during stability testing
Class III · Low risk Terminated
Vasotec
Reason Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Class III · Low risk Terminated
Vaseretic
Reason Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Class III · Low risk Terminated
Oasis TEARS
Reason Labeling: Missing Label; The label on the immediate bottle is missing.
Class III · Low risk Terminated
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold
Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk Terminated
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold
Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk Terminated
Olanzapine Orally Disintegrating Tablets 5 mg
Reason Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Class III · Low risk Terminated
Triveen - PRx RNF Capsules
Reason Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
Class III · Low risk Terminated
Wockhardt Metoprolol Succinate
Reason Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Class III · Low risk Terminated
Children's Triacting Night Time Cold & Cough with PE
Reason Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Class III · Low risk Terminated
Oxandrolone Tablets
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, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
Class III · Low risk Terminated
Day Time Cold & Flu
Reason Subpotent Drug: Phenylephrine component is subpotent.
Class III · Low risk Terminated
Haloperidol Decanoate Injection
Reason Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Class III · Low risk Terminated
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Class III · Low risk Terminated
Children's Cetirizine Hydrochloride Chewable Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Class III · Low risk Terminated
Cetirizine Hydrochloride Chewable Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide