🍔 Food 💊 Drugs 🏥 Medical Devices
Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05 Class III

Reason: Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

AVEVA Drug Delivery Systems, Inc. 20230215 Terminated
Distributed: Nationwide
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Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27 Class III

Reason: Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

Padagis US LLC 20230221 Ongoing
Distributed: Nationwide in the USA
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Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01 Class II

Reason: CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc 20230302 Terminated
Distributed: USA nationwide.
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Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01 Class II

Reason: CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc 20230302 Terminated
Distributed: USA nationwide.
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Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037. Class II

Reason: CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc 20230302 Terminated
Distributed: USA nationwide.
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Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037. Class II

Reason: CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc 20230302 Terminated
Distributed: USA nationwide.
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Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037. Class II

Reason: CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc 20230302 Terminated
Distributed: USA nationwide.
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Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037. Class II

Reason: CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc 20230302 Terminated
Distributed: USA nationwide.
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Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5 Class II

Reason: CGMP Deviations

Pharmedica USA, LLC 20230214 Ongoing
Distributed: Nationwide in the USA and Worldwide through e-commerce and trade shows
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Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ. Class I

Reason: Non-Sterility

Pharmedica USA, LLC 20230214 Ongoing
Distributed: Nationwide in the USA and Worldwide through e-commerce and trade shows
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