Triangle Compounding Recalls Sodium Phosphate Injectable Due to Sterility Concerns
Triangle Compounding is recalling 54 vials of Sodium Phosphate Injectable because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 death, meeting the criteria for a Severe rating.
Plain-English summary
Triangle Compounding Pharmacy is recalling 54 vials of Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial. The affected product is identified by Lot #814748-LG14917 with an expiration date of 10/31/13. The recall is limited to distribution in North Carolina.
The recall was initiated due to laboratory results from a contract testing lab indicating microbial contamination. The FDA expressed concern that the test results obtained from the firm's contract lab may not be reliable, meaning the sterility of the products cannot be assured.
Healthcare providers and patients who have received this specific lot of Sodium Phosphate Injectable should discontinue use and contact Triangle Compounding Pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
- Manufacturer
- Triangle Compounding
- Category
- Drug — Injectable
- Affected units
- 54
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 #814748-LG14917
- Exp 10/31/13
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.
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