Class II · Moderate risk
Oxacillin for Injection
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
FDA Drug Recalls
1,103 recalls, newest first
Class III · Low risk
Methylprednisolone Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
Class III · Low risk
Seconal Sodium
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Class III · Low risk
Cyproheptadine Hydrochloride Syrup
Subpotency: product assayed and found OOS for cyproheptadine
Class III · Low risk
Sirolimus Tablets
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Class III · Low risk
Urea (50% Urea in a Cream Base)
Crystallization; complaints received by the manufacturer of crystals forming in product
Class III · Low risk
Ciprofloxacin OPTH 0.3% SOL
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Class II · Moderate risk
Chlorhexidine Gluco. 0.12% Oral Rinse
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Class III · Low risk
CEFTRIAXONE for Injection USP
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Class III · Low risk
Irbesartan and Hydrochlorothiazide Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Class III · Low risk
Pramipexole Dihydrochloride Extended Release Tablets
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Class III · Low risk
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE…
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Class III · Low risk
Lisinopril Tablets USP
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg)
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Class II · Moderate risk
Nitrofurantoin Oral Suspension
Failed Dissolution Specifications
Class III · Low risk
Oxycodone HCl
Failed Impurities/Degradation Specification; 9 month stability
Class III · Low risk
Doxycycline
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Class III · Low risk
Divalproex Sodium Delayed-release Tablets USP
Failed Tablet/Capsule Specifications
Class III · Low risk
Mycophenolate Mofetil
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.