Class II · Moderate risk
Pleo Quent SUPPOSITORIES 3X
Penicillin Cross Contamination
FDA Drug Recalls
1,055 recalls · Class II, newest first
Class II · Moderate risk
Pleo Nota- Quent DROPS 5X
Penicillin Cross Contamination
Class II · Moderate risk
Pleo Not PORTABLE SIPS 7X
Penicillin Cross Contamination
Class II · Moderate risk
Pleo Not PORTABLE SIPS
Penicillin Cross Contamination
Class II · Moderate risk
Pleo Not PORTABLE SIPS
Penicillin Cross Contamination
Class II · Moderate risk
Pleo Not DROPS
Penicillin Cross Contamination
Class II · Moderate risk
Pleo Not TABLETS 5X
Penicillin Cross Contamination
Class II · Moderate risk
Pleo Not CAPSULES 4X
Penicillin Cross Contamination
Class II · Moderate risk
Pleo Not SUPPOSITORIES 3X
Penicillin Cross Contamination
Class II · Moderate risk
Pleo Not OINTMENT 3X
Penicillin Cross Contamination
Class II · Moderate risk
All sterile drugs compounded between 2/21/14 and 2/24/14.
Lack of Assurance of Sterility: All compounded products.
Class II · Moderate risk
Fluoxetine Capsules
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Class II · Moderate risk
etomidate injection
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
Class II · Moderate risk
BUPivacaine HCl 0.25% Preservative Free
Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.
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 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 II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
Class II · Moderate risk
Alprazolam 1 mg Tablets
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Class II · Moderate risk
Bupivacaine HCl Inj. USP
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Class II · Moderate risk
Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Class II · Moderate risk
Alprazolam Extended-Release Tablets
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Class II · Moderate risk
HydrOXYzine HCl Tablets
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class II · Moderate risk
HydrOXYzine HCl Tablets
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.