Class II · Moderate risk Ongoing
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Reason Chemical contamination: presence of benzene
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton…
Reason Chemical contamination: presence of benzene
Class II · Moderate risk Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC…
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk Ongoing
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60…
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm…
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics…
Reason Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Class II · Moderate risk Ongoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT…
Reason Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)…
Reason Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)…
Reason Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk Completed
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg…
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II · Moderate risk Completed
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg…
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC…
Reason cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an…
Class II · Moderate risk Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser…
Reason cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an…
Class II · Moderate risk Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL…
Reason Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Class II · Moderate risk Ongoing
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ…
Reason Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk Ongoing
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick…
Reason Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk Ongoing
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class III · Low risk Ongoing
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC…
Reason Cross Contamination
Class III · Low risk Ongoing
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC…
Reason Cross Contamination
Class III · Low risk Terminated
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed…
Reason Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.