The Recall Desk
SevereFDA (Drugs)·D-1069-2013·Announced 2013-10-09

Triangle Compounding Recalls Histamine Injectable Due to Sterility Concerns

Triangle Compounding Pharmacy is recalling 8 vials of Histamine, 10 ng/mL Injectable due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

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 microbial contamination of an injectable product, which poses a significant risk of serious injury or hospitalization.

Plain-English summary

Triangle Compounding Pharmacy is recalling 8 vials of Histamine, 10 ng/mL Injectable, prescription only. The specific lot affected is 74651-LG4973, with an expiration date of 12/4/13. The product was distributed in North Carolina.

The recall was initiated because laboratory results from a contract lab indicated microbial contamination. The FDA expressed concern that the test results obtained from the recalling firm's contract testing lab may not be reliable. Consequently, the sterility of the products cannot be assured.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
Affected units
8

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 (2)

  • Lot 74651-LG4973
  • Exp 12/4/13

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Triangle Compounding 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 2 products in this recall →

Same manufacturer · Triangle Compounding

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