Drug Recalls

Sprayology

Class II Terminated

Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0033-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0107-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0120-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0014-1 and Tester NDC 61096-1014

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0109-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0017-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0123-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0025-1 and Tester NDC 61096-1025-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0106-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0038-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0122-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0003-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0111-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0035-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0105-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0117-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0004-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0126-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0113-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007-1. and Tester NDC 61096-1007-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0115-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0110-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879NDC 61096-0023-1 and Tester NDC 61096-1023-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0121-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0034-1 and Tester NDC 61096-1034-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0108-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0027-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0124-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001-1 and Tester NDC 6196-1001-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0114-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0006-1 and Tester NDC 61096-1006-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0119-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0002-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0112-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0030-1 and Tester NDC 61096-1030-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0116-2019 November 7, 2018 Gaithersburg, MD

Sprayology

Class II Terminated

Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0039-1

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

D-0125-2019 November 7, 2018 Gaithersburg, MD

Valeant Pharmaceuticals North America LLC

Class II Terminated

Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011

Reason: CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive r...

D-0085-2019 October 31, 2018 Bridgewater, NJ

Valeant Pharmaceuticals North America LLC

Class II Terminated

Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028

Reason: CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive r...

D-0084-2019 October 31, 2018 Bridgewater, NJ

Valeant Pharmaceuticals North America LLC

Class II Terminated

Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155

Reason: CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive r...

D-0086-2019 October 31, 2018 Bridgewater, NJ

Product Quest Manufacturing LLC

Class II Terminated

CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.

Reason: Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.

D-0071-2019 October 24, 2018 Daytona Beach, FL

FDA Enforcement Report