💊 Drugs Class I - Dangerous
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
All Recalls
95,018 total recalls in our database
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Aspen Biopharma Labs Pvt.
💊 Drugs Class I - Dangerous
CGMP Deviations
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
Aspen Biopharma Labs Pvt.
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Presence of foreign tablets/capsules
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
Denison Pharmaceuticals
💊 Drugs Class I - Dangerous
Chemical Contamination: Presence of benzene.
💊 Drugs Class I - Dangerous
Chemical Contamination
💊 Drugs Class I - Dangerous
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
Breckenridge Pharmaceutical
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Alprostadil Container Description: Amber color bottle
Aspen Biopharma Labs Pvt.
💊 Drugs Class I - Dangerous
CGMP Deviations
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Breckenridge Pharmaceutical
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Nephron Sterile Compounding Center
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Aspen Biopharma Labs Pvt.
💊 Drugs Class I - Dangerous
CGMP Deviations
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.
Central Admixture Pharmacy Services
💊 Drugs Class I - Dangerous
Presence of Particulate Matter
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10
Breckenridge Pharmaceutical
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
Sigan Industries Group
💊 Drugs Class I - Dangerous
Chemical Contamination: Presence of benzene
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Aspen Biopharma Labs Pvt.
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
💊 Drugs Class I - Dangerous
Chemical Contamination
💊 Drugs Class I - Dangerous
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
Aspen Biopharma Labs Pvt.
💊 Drugs Class I - Dangerous
CGMP Deviations