🍔 Food 💊 Drugs 🏥 Medical Devices
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240304 Ongoing
Distributed: Nationwide
View Details
Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com Class III

Reason: Failed Dissolution Specifications: results slightly under spec at at 9-months.

Stason Pharmaceuticals, Inc. 20240209 Terminated
Distributed: USA Nationwide
View Details
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01 Class II

Reason: Failed Dissolution Specifications

Eugia US LLC 20240220 Ongoing
Distributed: OH, TN, LA, MS
View Details
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60 Class III

Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Contract Pharmaceuticals Limited Canada 20240220 Ongoing
Distributed: Nationwide in the U.S. and Puerto Rico
View Details
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61 Class III

Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Contract Pharmaceuticals Limited Canada 20240220 Ongoing
Distributed: Nationwide in the U.S. and Puerto Rico
View Details
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42 Class II

Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Denver Solutions, LLC DBA Leiters Health 20240220 Ongoing
Distributed: Nationwide in the USA
View Details
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42 Class II

Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Denver Solutions, LLC DBA Leiters Health 20240220 Ongoing
Distributed: Nationwide in the USA
View Details
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42 Class II

Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Denver Solutions, LLC DBA Leiters Health 20240220 Ongoing
Distributed: Nationwide in the USA
View Details
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471 Class II

Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Seatex LLC 20240219 Terminated
Distributed: Nationwide in the US and Puerto Rico
View Details
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033 Class II

Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Seatex LLC 20240219 Terminated
Distributed: Nationwide in the US and Puerto Rico
View Details
Page 190 of 1,805 | Showing 10 recalls
Data provided by openFDA