Class II · Moderate risk
Sildenafil 200 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Progesterone E4M SR 100 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Progesterone 50 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Progesterone 200 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Naltrexone 4.5 mg capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Magic Bullet Supplement
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Liothyronine
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Liothyronine
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Finasteride/Biotin 1 mg/50 mcg
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
DHEA/Pregnenol One 10.25 MG Cap
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10…
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk
Estriol
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.