🍔 Food 💊 Drugs 🏥 Medical Devices
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4 Class II

Reason: Short Fill

Nephron Sc Inc 20230113 Terminated
Distributed: Nationwide within the United States including Puerto Rico. Guatamala
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Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03 Class III

Reason: Subpotent Drug: Low assay result observed during long-term stability testing.

Lupin Pharmaceuticals Inc. 20230120 Terminated
Distributed: USA Nationwide
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Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383-09. Class II

Reason: Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Preferred Pharmaceuticals, Inc. 20230116 Terminated
Distributed: IN
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FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01. Class III

Reason: Short Fill: Underfilled units.

OurPharma LLC 20230113 Terminated
Distributed: IL and MO
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Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05. Class II

Reason: Failed Dissolution Specification

Ascend Laboratories, LLC 20230105 Terminated
Distributed: Nationwide and Puerto Rico
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Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01. Class II

Reason: Failed Dissolution Specification

Ascend Laboratories, LLC 20230105 Terminated
Distributed: Nationwide and Puerto Rico
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Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01. Class II

Reason: Failed Dissolution Specification

Ascend Laboratories, LLC 20230105 Terminated
Distributed: Nationwide and Puerto Rico
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Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01 Class II

Reason: Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Accord Healthcare, Inc. 20230112 Terminated
Distributed: Nationwide in the USA
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SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01. Class III

Reason: Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

Intersect ENT, Inc. 20230104 Terminated
Distributed: Nationwide
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SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Beverages, LLC, Lincoln, NE 68522 and Bottled by South Tenth Development, LLC, Lincoln, NE 68522. Class II

Reason: CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.

Southwest Iowa Renewable Energy LLC 20221006 Ongoing
Distributed: IA, NE
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