🍔 Food 💊 Drugs 🏥 Medical Devices
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 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
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PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 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
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PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 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
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Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30. Class II

Reason: Subpotent Drug: Out of specification for assay

Bausch Health Companies, Inc. 20240202 Completed
Distributed: Nationwide
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Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356 Class II

Reason: Lack of Assurance of Sterility

Brassica Pharma Pvt Ltd 20240130 Ongoing
Distributed: Nationwide within the United States
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CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141 Class II

Reason: Lack of Assurance of Sterility

Brassica Pharma Pvt Ltd 20240130 Ongoing
Distributed: Nationwide within the United States
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Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304 Class II

Reason: Lack of Assurance of Sterility

Brassica Pharma Pvt Ltd 20240130 Ongoing
Distributed: Nationwide within the United States
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Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298 Class II

Reason: Lack of Assurance of Sterility

Brassica Pharma Pvt Ltd 20240130 Ongoing
Distributed: Nationwide within the United States
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Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13. Class II

Reason: Failed Dissolution Specifications: Out of specification for dissolution.

SUN PHARMACEUTICAL INDUSTRIES INC 20240205 Ongoing
Distributed: Nationwide in the U.S.
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Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15 Class II

Reason: CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Golden State Medical Supply Inc. 20240214 Ongoing
Distributed: Nationwide in the USA
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