Isomeric Pharmacy Recalls Triamcinolone Diacetate Injectable Suspension Due to Labeling Errors
Isomeric Pharmacy Solution, LLC is recalling 114 vials of Triamcinolone Diacetate Injectable Suspension because some vials may have incorrect lot numbers or expiration dates.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is limited to labeling errors regarding dates and lot numbers, which is a documentation and packaging problem rather than a direct contamination or structural defect.
Plain-English summary
Isomeric Pharmacy Solution, LLC is recalling 114 vials of Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection. The product is a prescription-only injectable suspension manufactured in Salt Lake City, Utah, and distributed nationwide.
The recall was initiated due to labeling errors. Some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or Before Use Date (BUD). These dates may be longer than intended, which could affect the safety and efficacy of the medication.
Healthcare providers and patients who have this specific product should stop using it and contact their pharmacist or the recalling firm for further instructions. The affected lot number is 12212015@8, with a "Do Not Use Beyond" date of 03/22/2016 and a compounding date of December 21, 2015.
The recalled product
- Product
- Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109
- Manufacturer
- Isomeric Pharmacy Solution, LLC
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 114
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 (4)
- Lot Number: 12212015@8
- Do Not Use Beyond: 03/22/2016
- "Compounded on December 21
- 2015"
Distribution
Distributed nationwide across the United States.
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