Class II · Moderate risk
CLONAZEPAM ORALLY DISINTERGRATING Tablets
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Ciprofloxacin Tablets USP
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Class III · Low risk
buPROPion Hydrochloride Extended Release Tablets
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Class II · Moderate risk
Benjamins Infants Gripe Mixture
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Class III · Low risk
Tev-Tropin
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Class III · Low risk
Calcium Gluconate Injection
Labeling: Missing label
Class I · High risk
Vistide (cidofovir)
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Class II · Moderate risk
Daytrana (methylphenidate)
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Class III · Low risk
Suprax (cefixime for oral suspension)
Discoloration; Product may not meet specifications for color description once reconstituted.
Class II · Moderate risk
ZoDen PD
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
ZoDen DM Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Syrup
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Pediatric Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Trigofen DM Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Trigofen Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Tri-Dex PE
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
TL-Hist PD Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
TL Hist DM
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Tl-Dex Dm
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Mesehist WC
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Mesehist DM
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
CPM / PSE DM Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
CPM / PSE Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
TG 40PSE/400GFN Tablets
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Poly-Vent IR
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.