Policy & LawPublic Health

Stay Safe By Being Aware Of These 2019 FDA Drug Recalls

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A drug recall is the Federal Food and Drug Administration?s way of protecting the public by removing harmful drugs from being available in pharmacies, drug stores, and store shelves. It basically removes a drug, both over-the-counter and prescribed, from the market. A recall is a voluntary action taken by a company when they?ve realized, or have been alerted, that their product jeopardizes the safety of users.

2019 has already started with a few drug recalls. Be aware of the recalled product and the descriptions listed below, as many times a product under a different name can be sold with the same harmful active ingredients as a recalled drug. Even when the FDA has issued a recall for a product, some consumers may still have obtained injuries from these dangerous drugs prior to their recall. If this is your case, it might be a good idea to consult with an attorney to learn if your injuries are aligned with those reported by the FDA and whether you are able to seek compensation for any of the injuries they may have caused you – including medical bills, surgeries, etc.

Pharmaceutical companies make an extraordinary amount of money on the drugs that intend to keep users alive and healthy. The least they can do is ensure those drugs are effective and safe.

2019 FDA Drug Recalls

CVS, Equate  Oral Ibprofen

Date of Recall: 1/29/19

Reason for Recall: Higher levels of Ibprofen concentration

Company: Tris Pharma, Inc.

Recall also includes the following products:

  • Equate: Infants? Ibuprofen Concentrated Oral Suspension
  • CVS Health: Infants? Ibuprofen Concentrated Oral Suspension
  • Equate: Ibuprofen Oral Suspension Drops
  • Family Wellness: Ibuprofen Oral Suspension Drops

Torrent Pharmaceuticals Limited, Losartan potassium tablets, USP; losartan potassium hydrochlorothiazide combination tablets, USP

Date of Recall: 1/22/19

Reason for Recall: Detection of trace amounts of N-nitrosodiethylamine (NDEA)

Company: Torrent Pharmaceuticals Limited

Recall also includes the following products:

  • Losartan Potassium and Hydrochlorothiazide Tabelets, USP
  • Losartan Potassium Tab, USP

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC, Irbesartan and Irbesartan HCTZ Tablets  

Date of Recall: 1/18/19

Reason for Recall: Higher levels of Ibprofen concentration

Company: Tris Pharma, Inc.

Recall also includes the following products:


Rhino  Rhino 5K capsules  

Date of Recall: 1/08/19

Reason for Recall: Unapproved new drug and presence of undeclared Sildenafil and Tadalafill

Company: Happy Together, Inc.

Sun Pharma, Vecuronium Bromide for Injection  

Date of Recall: 1/08/19

Reason for Recall: Particulate matter. Voluntary nationwide recall of Vecuronium Bromide for injection due to the presence of particulate matter identified as glass

Company: Tris Pharma, Inc.

Recall also includes the following products:

  • Vecuronium Bromide for Injection, 20 mg
  • Vecuronium Bromide for Injection, 10 mg

Lupin Pharmaceuticals, Inc., Ceftriaxone for Injection, USP

Date of Recall: 1/05/19

Reason for Recall: Products contain visual grey particulate matter in reconstituted vial. Improper piercing and use of needles larger than 21 gauge can push rubber material into the solution. The issue was identified by medical professional throughout visual inspection of solutions prior to administering to patients. According to the FDA report, this recalled product (containing rubber material) could cause ?vein irritation/phlebitis or pulmonary embolic events? and even damage to the body?s lung and vascular system if injected.

Company: Tris Pharma, Inc.

Recall also includes the following products:

  • Ceftriaxone for Injection USP, 250mg
  • Ceftriaxone for Injection USP, 500mg
  • Ceftriaxone for Injection USP, 1g
  • Ceftriaxone for Injection USP, 2g

Aurobindo, Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP

Date of Recall: 12/31/18

Reason for Recall: Detection of N-nitrosodiethylamine (NDEA) impurity.

Company: Tris Pharma, Inc.

Recall also includes the following products:

  • Amlodipine and Valsartan Tablets USP5mg/160mg
  • Amlodipine and Valsartan Tablets USP10mg/160mg
  • Amlodipine and Valsartan Tablets USP10mg /320mg
  • Amlodipine and Valsartan Tablets USP10mg/160mg
  • Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg
  • Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg
  • Valsartan Tablets USP 320mg

Final Thoughts

It may come as a surprise that there are already 2019 FDA drug recalls so early in the year, but keeping them on your radar is important. It’s always better to be safe than sorry, so remain vigilant about drug safety and recalls. Be sure to double check about any medicines you may have that are differently named but have the same active ingredients as the recalled drugs. Stay safe for a healthier 2019.

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About author
Brenda is a University of California, Santa Barbara alumna with a passion for sharing information on public health, consumer safety, organic health and travel. She enjoys the outdoors and seeking new experiences to share with the world. For inquiries, contact her by email at belazab@gmail.com.
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