Class I - Dangerous
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
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Prescription Drugs
💊 Drugs • 12,141 recalls
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class I - Dangerous
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Class I - Dangerous
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class I - Dangerous
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class I - Dangerous
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class I - Dangerous
Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.
Class I - Dangerous
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Class I - Dangerous
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class I - Dangerous
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Boehringer Ingelheim Roxane
Class I - Dangerous
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3
Ferring Pharmaceuticals
Class I - Dangerous
Discoloration; due to prolonged heat exposure.
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Brookfield Prescription Center Inc.
Class I - Dangerous
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Brookfield Prescription Center Inc.
Class I - Dangerous
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Brookfield Prescription Center Inc.
Class I - Dangerous
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class I - Dangerous
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Brookfield Prescription Center Inc.
Class I - Dangerous
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.