The Recall Desk
SevereFDA (Drugs)·D-1129-2014·Announced 2014-03-12

Recall of Pyridoxine Injection Due to Sterility Assurance Concerns

Natures Pharmacy & Compounding Center is recalling all lots of Pyridoxine (p-f) 100mg/ml due to quality control issues affecting sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in injectable products.

Plain-English summary

Natures Pharmacy & Compounding Center is recalling all lots of Pyridoxine (p-f) 100mg/ml. The recall includes all sterile products compounded by the pharmacy that are not expired.

The recall was initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection.

The distribution pattern is listed as NC. Consumers and healthcare providers should stop using the recalled product and contact the pharmacy for further instructions.

The recalled product

Product
Pyridoxine (p-f) 100mg/ml

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 lot numbers within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 48 recalled by Natures Pharmacy & Compounding Center 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 48 products in this recall →