The Recall Desk
ModerateFDA (Drugs)·D-1084-2016·Announced 2016-07-13

Reliable Drug Recalls T4-Levothyroxine Products Due to Processing Control Deficiencies

Reliable Drug is recalling all T4-levothyroxine products compounded between March 2015 and March 2016 due to a lack of processing controls.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any specific illnesses or injuries, and the hazard is related to processing controls rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Reliable Drug/Reliable Compounding Pharmacy is recalling all T4-levothyroxine products, which are prescription-only medications. The recall is being conducted because of a lack of processing controls at the facility.

The affected products were compounded by Reliable Drug/Reliable Compounding Pharmacy located at 801 Irving St., San Francisco, CA 94122. The recall covers all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates.

Distribution of these products included California, Hawaii, and New Mexico. Consumers who have these products should contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product
All T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Manufacturer
Reliable Rexall-A Compounding Pharmacy
Category
Drug — Compounded Prescription Medication
Hazard

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 →

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