The Recall Desk
SevereFDA (Drugs)·D-1126-2014·Announced 2014-03-12

Papaverine Injection Recalled for Lack of Sterility Assurance

Natures Pharmacy & Compounding Center is recalling Papaverine 1nj 30mg/ml due to quality control concerns that present a potential risk to 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 source text identifies a lack of sterility assurance in a sterile injectable product, which presents a significant risk of serious injury or death from infection, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Natures Pharmacy & Compounding Center is recalling all lots of Papaverine 1nj 30mg/ml 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 agency has classified this recall as Class II.

The recall applies to all lots of sterile products compounded by the pharmacy that are not expired. Consumers should contact their healthcare provider or the pharmacy for further instructions regarding the use of these products.

The recalled product

Product
Papaverine 1nj 30mg/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 →