Home / Recalls / Sprayology / D-0114-2019

D-0114-2019 Class II Terminated

Recalled by Sprayology — Gaithersburg, MD

Recall Details

Product Type
Drugs
Report Date
November 7, 2018
Initiation Date
October 9, 2018
Termination Date
April 18, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,393 bottles

Product Description

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 for Recall

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

All lots within expiry

Other recalls by Sprayology

  • D-0112-2019 Class II — Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for (October 9, 2018)
  • D-0117-2019 Class II — Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray (October 9, 2018)
  • D-0113-2019 Class II — DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray (October 9, 2018)
  • D-0115-2019 Class II — TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayol (October 9, 2018)
  • D-0116-2019 Class II — Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray (October 9, 2018)
  • D-0107-2019 Class II — Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayol (October 9, 2018)
  • D-0121-2019 Class II — Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayo (October 9, 2018)
  • D-0118-2019 Class II — Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra (October 9, 2018)
  • D-0122-2019 Class II — ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spra (October 9, 2018)
  • D-0123-2019 Class II — Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sp (October 9, 2018)