Subpotent Drug; Ethinyl Estradiol
Prescription Drugs
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Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01
Boehringer Ingelheim Pharmaceuticals
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
Boehringer Ingelheim Pharmaceuticals
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Superpotent Drug: Failure of assay specifications in the capsule.
PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
Dream Body Weight Loss
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Dream Body Weight Loss
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
Dream Body Weight Loss
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.
Pharmedium Services
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234.
Pharmedium Services
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.