Isomeric Pharmacy Recalls Triamcinolone Injection Vials Due to CGMP Deviations
Isomeric Pharmacy Solution is recalling 6,999 vials of Triamcinolone 40 mg/mL injection due to Current Good Manufacturing Practice (CGMP) deviations.
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, which corresponds to a Severe severity score under the rubric, as it involves a reasonable probability of temporary or medically reversible adverse health consequences.
Plain-English summary
Isomeric Pharmacy Solution, LLC is voluntarily recalling 6,999 single-use vials of Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only. The product is compounded by Isomeric Pharmacy Solutions in Salt Lake City, Utah, and carries the NDC 70285-1920-1. The recall was initiated on March 8, 2017, and was classified as Class II by the FDA.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected lots include #08016, #08018, #08023, #08026, #08033, #09004, #11014, and #11031, with expiration dates ranging from March 14, 2017, to June 20, 2017. The product was distributed nationwide.
Patients who have received this medication should consult their healthcare provider for guidance on whether to continue using the product or seek an alternative. The recall status is terminated as of May 25, 2017.
The recalled product
- Product
- Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1
- Manufacturer
- Isomeric Pharmacy Solution, LLC
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 6,999
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 (9)
- Lot #08016
- Exp. 03/14/17 Lot #08018
- Exp. 03/15/17 Lot #08023
- Exp. 03/22/17 Lot #08026
- Exp. 03/19/17 Lot #08033
- Exp. 03/28/17 Lot #09004
- Exp. 04/03/17 Lot #11014
- Exp. 06/10/17 Lot #11031
- Exp. 06/20/17
Distribution
Distributed nationwide across the United States.
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