Hospice Medication Alert: Hydrochlorothiazide 25mg Tablet Recall

 In Recall

On July 30, 2015, Unichem Pharmaceuticals issued a voluntary recall of a specific lot of their Hydrochlorothiazide 25mg tablets as a Plavix (clopidogrel) tablet was found in a bottle of the product. The FDA has notified distributors and pharmacies about the recall.  The dispensing pharmacies were expected to identify patients received the specific lot of medication and to bring this to the attention of the consumer level. Unichem has stated that this episode is an isolated event noted at one pharmacy and confined to the recalled lot.  They have not received any reports of adverse events related to this recall to date.

The risk of mistakenly taking a Clopidogrel tablet instead of a Hydrochlorothiazide tablet may include an increased risk of side effects associated with Clopidogrel, which include bleeding and/or bruising. Patients with active bleeding or who are allergic to Clopidogrel or any component of the formulation may experience more serious adverse health consequences as a result of unknowingly consuming Clopidogrel. Additionally, missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema).

The affected Hydrochlorothiazide 25mg lot is GHYL15028 – expiration April 2018. It was packaged in 1000-count bottles and were distributed nationwide directly to wholesalers, retailers and pharmacies from May 21 – 28, 2015.  The tablets can be identified as a round light orange/yellow tablet with a beveled edge, with a score mark and U 128 imprint.

There is a “drug identifier tool” under Clinical Resources in the Client Resources section of our web-site: hospicepharmacysolutions.com. You can identify a pill by entering the shape, color, imprint, dosage-form, or scoring on a tablet.  This may be very helpful when loose pills are found in the patient’s home or in cases such as this when different tablets are found in the same prescription bottle.

Outcome Resources is including this information on our blog for the hospice clinicians since Hydrochlorothiazide is widely used in hospice for a variety of indications and this news may impact your patients. It is advisable to check with your patients who have current orders for Hydrochlorothiazide 25mg and evaluate if they are affected by this recall.  If you suspect that one of your patients has the affected product, call the pharmacy which dispensed the prescription and have the prescription label in hand to provide necessary information to the dispensing pharmacy to verify the lot information for you.  In the event you encounter the recalled product, return it to the pharmacy that dispensed it for a replacement.

If you are an HPS client, the clinical team will reach out to you if we have suspected that one of your patients has received Hydrochlorothiazide from this manufacturer.

Click here for more information on the voluntary recall.


Leave a Comment