The Recall Desk
ModerateFDA (Drugs)·D-1100-2016·Announced 2016-07-13

Reliable Compounding Pharmacy Recalls Nifedipine Products Due to Processing Controls

Reliable Compounding Pharmacy is recalling all nifedipine 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, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses or injuries, aligning with a moderate severity rating for a voluntary precautionary recall due to processing controls.

Plain-English summary

Reliable Rexall-A Compounding Pharmacy is recalling all nifedipine products, which are prescription-only medications. The recall is being conducted because of a lack of processing controls.

The affected products were compounded by Reliable Drug/Reliable Compounding Pharmacy located in San Francisco, California. The recall includes all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates.

These products were distributed in the United States, specifically in California, Hawaii, and New Mexico. Consumers should stop using these products and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
All nifedipine 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 →