FEROMAC-DROPS

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

3-1-2019

Results RNA LLC Issues Voluntary Worldwide/Nationwide Recall of Lubrisine Eye Drops Due to Manufacturing Sterility Concerns and Undeclared Colloidal Silver

Results RNA LLC is voluntarily recalling Lubrisine Eye Drops to the healthcare practitioner, retail or consumer level. This product, in a recent FDA inspection, was found to be manufactured using practices that do not support its sterility and contained undeclared colloidal silver.

FDA - U.S. Food and Drug Administration

7-12-2018

Strawberry-flavoured acetaminophen infant oral drops in 24 mL bottles recalled because of defective child-resistant safety caps

Laboratoire RivaInc. and Laboratoires Trianon Inc. are voluntarily recalling five over-the-counter strawberry-flavoured acetaminophen oral drops for infants. The products are labeled as Biomedic, Option, Personnelle, Selection, or Laboratoires Trianon Inc. The products are packaged in 24 mL bottles and are used for pain and fever relief. They are being recalled because the child-resistant safety cap may be defective. This recall is in addition to previous recalls of children’s acetaminophen syrups for th...

Health Canada

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

4-7-2018

Human medicines European public assessment report (EPAR): Cystadrops, mercaptamine, Revision: 2, Authorised

Europe - EMA - European Medicines Agency

21-5-2018

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity

FDA - U.S. Food and Drug Administration

18-5-2018

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.

FDA - U.S. Food and Drug Administration

26-11-2018

An infusion pump whose predicate device uses older “beam break” technology to estimate the size of the drop. The new device uses a video camera and vision processing to monitor the drop formation and detect drops falling, making the device more precise a

An infusion pump whose predicate device uses older “beam break” technology to estimate the size of the drop. The new device uses a video camera and vision processing to monitor the drop formation and detect drops falling, making the device more precise and more accurate.

FDA - U.S. Food and Drug Administration