Drug recall: All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN…

U.S. Including: CA, HI, NM

Reliable Rexall-A Compounding Pharmacy, San Francisco, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

The table shows 60 of 70 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

Drug events that started in 2016

288

Share of these events in Class I

11%

Product records in this event

70

Events of the firm on the register

1

• FDA enforcement report D-1067-2016The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Where was the product distributed?

The FDA record gives this distribution: U.S. Including: CA, HI, NM

What quantity of product is in FDA event 73662?

The event has 70 product records. The first record gives this quantity: N/A

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many drug recalls of 2016 have the same class?

11% of the 288 drug events that started in 2016 are in Class I.