The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1115-2016·Announced 2016-07-13

Reliable Drug Recalls Quinacrine Products Due to Processing Control Deficiencies

Reliable Drug is recalling all compounded quinacrine products due to a lack of processing controls. The recall affects products distributed in California, Hawaii, and New Mexico.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 corresponds to a Moderate severity score when no specific hospitalizations or severe injuries are reported, aligning with the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

Reliable Drug/Reliable Compounding Pharmacy is recalling all quinacrine products, which are prescription-only medications compounded by the firm. The recall is being conducted due to a lack of processing controls. The affected products were compounded between March 24, 2015, and March 24, 2016, and are within their expiration dates.

The recall covers all lots of these products distributed in the United States, specifically including California, Hawaii, and New Mexico. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for further instructions. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
All quinacrine 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
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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