The Recall Desk
SevereFDA (Drugs)·D-904-2015·Announced 2015-04-29

Attix Pharmaceuticals Recalls Streptomycin Sulfate Due to Penicillin Cross-Contamination Risk

Attix Pharmaceuticals is recalling Streptomycin Sulfate API because it was repackaged in a facility with penicillin products without adequate separation, creating a cross-contamination risk.

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 and involves a risk of penicillin cross-contamination, which can cause severe allergic reactions or anaphylaxis in sensitive individuals, meeting the criteria for a Severe rating.

Plain-English summary

Attix Pharmaceuticals is recalling all lots of Streptomycin Sulfate or Sulphate active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product is packaged in varying grams or kilograms in bags or drums. The total quantity involved is 30,500 grams.

The recall was initiated because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin. The FDA has classified this recall as Class II.

The affected product was distributed nationwide to compounding pharmacies and research organizations. Compounding pharmacies and research organizations should stop using the product and contact the recalling firm for instructions on return or disposal. Patients who have received medications compounded with this ingredient should consult their healthcare provider.

The recalled product

Product
Streptomycin Sulfate or Sulphate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

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 repackaged and distributed between 01/05/12 to 02/12/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 470 recalled by Attix Pharmaceuticals 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 470 products in this recall →