The Recall Desk
HighFDA (Drugs)·D-1118-2016·Announced 2016-07-13

Reliable Compounding Pharmacy Recalls Diltiazem Products Due to Processing Controls

Reliable Compounding Pharmacy is recalling all diltiazem products compounded between March 2015 and March 2016 due to a lack of processing controls.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) in the absence of reported hospitalizations or injuries, as per the rubric.

Plain-English summary

Reliable Rexall-A Compounding Pharmacy is recalling all diltiazem products, prescription only, compounded by the pharmacy located in San Francisco, California. The recall covers all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates.

The recall was initiated due to a lack of processing controls. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed in the United States, including California, Hawaii, and New Mexico. Patients who have received these products should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 70 recalled by Reliable Rexall-A Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 70 products in this recall →