United Therapeutics Recalls Tyvaso Inhalation Devices Due to Manufacturing Deviations
United Therapeutics is voluntarily recalling 12 Tyvaso Inhalation System Starter Kits due to Current Good Manufacturing Practice (CGMP) deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations. Per the rubric, minor labeling errors, low-risk contamination, or voluntary precautionary recalls without reported injuries or illnesses typically fall under Moderate severity.
Plain-English summary
United Therapeutics Corporation has voluntarily recalled 12 units of the TYVASO (treprostinil) Inhalation System Starter Kit, Model# TD-100/A. The recall was initiated on September 11, 2017, and was reported to the FDA on November 29, 2017. The affected products are prescription-only inhalation solutions containing treprostinil 1.74 mg/2.9 mL (0.6 mg/mL).
The reason for the recall is identified as Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The recall was voluntarily initiated by the firm.
The affected lots are Lot # 2101152 (Expiration: 12/11/2017) and Lot # 2101195 (Expiration: 04/26/2019). The distribution pattern is listed as PA. The recall status is currently Terminated, with a termination date of April 3, 2019. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact United Therapeutics or their healthcare provider for further instructions.
The recalled product
- Product
- TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601
- Manufacturer
- United Therapeutics Corp.
- Category
- Drug — Inhalation Solution
- Hazard
- Affected units
- 12
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 (3)
- Lot #: 2101152
- Exp. 12/11/2017 Lot #: 2101195
- Exp. 04/26/2019
Distribution
Distributed in 1 state:
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