The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1103-2016·Announced 2016-07-13

Reliable Drug Recalls Compounded Lidocaine, Meloxicam, Diclofenac, and Baclofen

Reliable Drug is recalling compounded lidocaine, meloxicam, diclofenac, and baclofen products 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Reliable Drug/Reliable Compounding Pharmacy is recalling all lidocaine, meloxicam, diclofenac, and baclofen products compounded by the firm. The recall is being conducted because of 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 expiry dates.

The recall covers products distributed in the United States, including California, Hawaii, and New Mexico. The FDA has classified this recall as Class II, which means there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected products and contact their pharmacist or healthcare provider for further instructions or a replacement.

The recalled product

Product
All lidocaine, meloxicam, diclofenac and baclofen 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 Medications
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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