💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
All Recalls
95,050 total recalls in our database
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
💊 Drugs Class I - Dangerous
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
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.
💊 Drugs 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.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
cGMP Deviations: Products may have microbial contamination.
💊 Drugs 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
💊 Drugs 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
💊 Drugs Class I - Dangerous
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
💊 Drugs Class I - Dangerous
cGMP Deviations: Products may have microbial contamination.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
💊 Drugs Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07.
Deva Holding AS - Cerkezkoy Subesi
💊 Drugs Class I - Dangerous
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
💊 Drugs Class I - Dangerous
cGMP Deviations: Products may have microbial contamination.
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), 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
💊 Drugs Class I - Dangerous
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.