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23 catalysts · 12 device 510k · 10 recall · 1 approval
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23 catalysts · 12 device 510k · 10 recall · 1 approval
Sponsor: ZYDUS PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15. — Reason: LABELING: LABEL MIX-UP — Status: Ongoing
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack — Reason: Crystallization — Status: Ongoing
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15. — Reason: Failed Dissolution Specifications — Status: Ongoing
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03 — Reason: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study. — Status: Terminated
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25 — Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. — Status: Terminated
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles — Reason: Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone. — Status: Ongoing
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25 — Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. — Status: Terminated
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 — Reason: Failed Impurities/Degradation Specifications — Status: Terminated
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack — Reason: Crystallization — Status: Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15 — Reason: LABELING: LABEL MIX-UP — Status: Ongoing
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: PCH. Advisory committee: Microbiology. Type: Special
Product code: JFB. Advisory committee: Physical Medicine. Type: Special
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: MSX. Advisory committee: Cardiovascular. Type: Traditional
Product code: LBH. Advisory committee: Dental. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Abbreviated
Product code: LZA. Advisory committee: General Hospital. Type: Special
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional