🍔 Food 💊 Drugs 🏥 Medical Devices
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13 Class III

Reason: Cross Contamination with Other Products

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. 20240409 Ongoing
Distributed: USA nationwide.
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Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc. Class III

Reason: Cross Contamination with Other Products

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. 20240409 Ongoing
Distributed: USA nationwide.
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Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13 Class III

Reason: Cross Contamination with Other Products

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. 20240409 Ongoing
Distributed: USA nationwide.
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FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01. Class II

Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Nomax Inc 20240419 Ongoing
Distributed: Nationwide in the USA
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FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03. Class II

Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Nomax Inc 20240419 Ongoing
Distributed: Nationwide in the USA
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GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40. Class II

Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Nomax Inc 20240419 Ongoing
Distributed: Nationwide in the USA
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GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123. Class II

Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Nomax Inc 20240419 Ongoing
Distributed: Nationwide in the USA
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Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37 Class II

Reason: CGMP Deviations

HONEYWELL INC 20240329 Terminated
Distributed: Nationwide USA, Canada
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Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5 Class I

Reason: Chemical Contamination: Product manufactured with ethanol API that contains methanol

Aruba Aloe Balm N.V. 20240323 Ongoing
Distributed: Nationwide in the USA
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Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. Class I

Reason: Chemical Contamination: Product manufactured with ethanol API that contains methanol

Aruba Aloe Balm N.V. 20240323 Ongoing
Distributed: Nationwide in the USA
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