Class II · Moderate risk Terminated
Progesterone 50 mg capsules
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
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Class II · Moderate risk Terminated
Progesterone 200 mg Troche
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Naltrexone 4.5 mg capsule
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Magic Bullet Supplement
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Liothyronine
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Liothyronine
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Finasteride/Biotin 1 mg/50 mcg
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
DHEA/Pregnenol One 10.25 MG Cap
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class I · High risk Terminated
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class II · Moderate risk Terminated
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class I · High risk Terminated
Panther Platinum 30000 Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk Terminated
Rhino 7 Platinum 30000 Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk Terminated
Stallion Platinum 30000 Capsules in blue
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk Terminated
Bull Platinum 30000 Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class II · Moderate risk Terminated
Hydrocortisone and Acetic Acid Otic Solution
Reason Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Class III · Low risk Terminated
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP
Reason Subpotent Drug
Class III · Low risk Terminated
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP
Reason Subpotent Drug
Class III · Low risk Terminated
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP
Reason Subpotent Drug
Class III · Low risk Terminated
Memantine Hydrochloride Extended-release Capsules
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk Terminated
Bimatoprost Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Class II · Moderate risk Terminated
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10…
Reason CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk Terminated
Estriol
Reason Subpotent Drug: Supplier indicated assay results did not meet specifications.
Class III · Low risk Terminated
Memantine Hydrochloride Extended-release Capsules
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.