The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1094-2016·Announced 2016-07-13

Reliable Compounding Pharmacy Recalls Boric Acid Products Due to Processing Controls

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

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 and involves a lack of processing controls without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Reliable Rexall-A Compounding Pharmacy is recalling all boric acid products compounded by the pharmacy. The recall is being conducted due to a lack of processing controls. The affected products are prescription-only and were compounded between March 24, 2015, and March 24, 2016, and are within their expiration dates.

The recalled products were distributed in the United States, including California, Hawaii, and New Mexico. The recall is classified as FDA Class II by the agency.

Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
All boric acid 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 →

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