Alprostadil Container Description: Amber color bottle
Aspen Biopharma Labs Pvt.
Class I - Dangerous
CGMP Deviations
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
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
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
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.
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
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
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
Class I - Dangerous
Chemical Contamination: Presence of benzene
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Aspen Biopharma Labs Pvt.
Class I - Dangerous
CGMP Deviations
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.
Class I - Dangerous
Chemical Contamination
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.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class I - Dangerous
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class I - Dangerous
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class I - Dangerous
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class I - Dangerous
Failed Impurities/Degradation Specifications