Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Wise Pharmacy
Class I - Dangerous
Lack of Processing Controls
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Prescription Drugs
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Class I - Dangerous
Lack of Processing Controls
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Lack of Processing Controls
Class I - Dangerous
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Class I - Dangerous
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class I - Dangerous
Lack of Processing Controls
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Wise Pharmacy
Class I - Dangerous
Lack of Processing Controls
Class I - Dangerous
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Deva Holding AS - Cerkezkoy Subesi
Class I - Dangerous
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class I - Dangerous
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Deva Holding AS - Cerkezkoy Subesi
Class I - Dangerous
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Dercher Enterprises, Inc.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Amneal Pharmaceuticals
Class I - Dangerous
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Deva Holding AS - Cerkezkoy Subesi
Class I - Dangerous
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class I - Dangerous
cGMP Deviations: Products may have microbial contamination.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.