🍔 Food 💊 Drugs 🏥 Medical Devices
Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA. Class II

Reason: CGMP Deviations

Golden State Medical Supply Inc. 20220316 Ongoing
Distributed: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
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Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40. Class II

Reason: CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.

SUN PHARMACEUTICAL INDUSTRIES INC 20220603 Terminated
Distributed: nationwide.
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CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 30594 2. Class I

Reason: Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens

Vi-Jon, LLC 20220613 Terminated
Distributed: Distributed Nationwide in the USA
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Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07 Class II

Reason: Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.

Macleods Pharma Usa Inc 20220616 Terminated
Distributed: Distributed Nationwide and Puerto Rico.
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Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430. Class III

Reason: Defective Container

Glenmark Pharmaceuticals Inc., USA 20220616 Terminated
Distributed: Nationwide in the USA
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Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16 Class II

Reason: Defective container: defect prevents product from dispensing as intended.

Akorn, Inc. 20220613 Terminated
Distributed: Nationwide USA
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Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01 Class II

Reason: CGMP Deviations

Glenmark Pharmaceuticals Inc., USA 20220629 Terminated
Distributed: One sole distributor in TX
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Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02 Class II

Reason: Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.

Akorn, Inc. 20220610 Terminated
Distributed: Nationwide in the U.S.
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Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3 Class II

Reason: Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.

Noven Pharmaceuticals Inc 20220624 Ongoing
Distributed: Distributed Nationwide in the USA
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Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01 Class I

Reason: Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

Akcea Therapeutics, Inc. 20220523 Terminated
Distributed: KY, USA
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