🍔 Food 💊 Drugs 🏥 Medical Devices
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936. Class III

Reason: Failed Impurities/Degradation Specifications.

Novartis Pharmaceuticals Corporation 20220510 Terminated
Distributed: Nationwide within the United States
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Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. Class III

Reason: Failed Impurities/Degradation Specifications.

Novartis Pharmaceuticals Corporation 20220510 Terminated
Distributed: Nationwide within the United States
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Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936. Class III

Reason: Failed Impurities/Degradation Specifications.

Novartis Pharmaceuticals Corporation 20220510 Terminated
Distributed: Nationwide within the United States
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Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60. Class I

Reason: Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.

Teva Pharmaceuticals USA Inc 20220511 Terminated
Distributed: Distributed Nationwide in the USA
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Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson & Johnson Consumer, Inc. Skillman, NJ 08558, UPC 3 81137-001530 7 Class II

Reason: cGMP deviations: product stored outside of labeled temperature requirements.

Family Dollar Stores, Llc. 20220517 Ongoing
Distributed: USA Nationwide
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Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9 Class II

Reason: cGMP deviations: product stored outside of labeled temperature requirements.

Family Dollar Stores, Llc. 20220517 Ongoing
Distributed: USA Nationwide
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Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6 Class II

Reason: cGMP deviations: product stored outside of labeled temperature requirements.

Family Dollar Stores, Llc. 20220517 Ongoing
Distributed: USA Nationwide
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AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g) Class II

Reason: cGMP deviations: product stored outside of labeled temperature requirements.

Family Dollar Stores, Llc. 20220517 Ongoing
Distributed: USA Nationwide
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AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g) Class II

Reason: cGMP deviations: product stored outside of labeled temperature requirements.

Family Dollar Stores, Llc. 20220517 Ongoing
Distributed: USA Nationwide
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AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g) Class II

Reason: cGMP deviations: product stored outside of labeled temperature requirements.

Family Dollar Stores, Llc. 20220517 Ongoing
Distributed: USA Nationwide
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