Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Atripla
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Class I · High risk
Acetylcysteine Solution
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
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 I · High risk
Citrulline
Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.
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 I · High risk
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Class III · Low risk
QVAR¿ (beclomethasone dipropionate HFA)
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Class III · Low risk
Tivicay (dolutegravir)
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
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 III · Low risk
Photofrin (porfimer sodium)
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
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 III · Low risk
Gelnique (oxybutynin chloride)
Subpotent Drug: Drug potency was compromised during shipment.
Class III · Low risk
Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
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.