The Recall Desk
ModerateFDA (Drugs)·D-1134-2016·Announced 2016-07-13

Reliable Compounding Pharmacy Recalls All Baclofen Products Due to Processing Controls

Reliable Compounding Pharmacy is recalling all baclofen 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Reliable Rexall-A Compounding Pharmacy is recalling all baclofen products compounded by the pharmacy. The recall is being conducted due to a lack of processing controls.

The affected products are prescription-only baclofen compounded by Reliable Drug/Reliable Compounding 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 products were distributed in the United States, including California, Hawaii, and New Mexico. Consumers with these products should contact their healthcare provider or pharmacist for guidance on what to do next.

The recalled product

Product
All baclofen 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 →