The Recall Desk
SevereFDA (Drugs)·D-1117-2014·Announced 2014-03-12

Natures Pharmacy Recalls Sterile Compounded Products Due to Sterility Assurance Concerns

Natures Pharmacy & Compounding Center is recalling all lots of sterile compounded products 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 severity score per the rubric, particularly given the risk to sterility assurance in compounded sterile products.

Plain-English summary

Natures Pharmacy & Compounding Center is recalling all lots of sterile products compounded by the pharmacy that are not expired. The recall is due to concerns associated with quality control procedures that present a potential risk to sterility assurance.

These quality control concerns were observed during a recent FDA inspection. The specific products involved include Glutathione 6%/ascorbic 1%/DMSO 6.25%. The distribution pattern is listed as NC, and the code information indicates all lot numbers within expiry.

Consumers who have these products should stop using them and contact the pharmacy for further instructions. The recall is classified as FDA Class II.

The recalled product

Product
Glutathione 6%/ascorbic 1%/DMSO 6.25%

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 →