Tirzepatide injection 15 mg vials recalled over sterility assurance failure
New Life Pharma is recalling one lot of Tirzepatide Injection 15 mg x 4 sterile multi-dose vials for lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of an injectable medicine whose sterility cannot be assured, with no injuries stated in the source.
Plain-English summary
New Life Pharma LLC is recalling Tirzepatide Injection, 15 mg x 4, sterile multi-dose vial, prescription only, labelled for Nomida of Olathe, Kansas, NDC 84223-002-04. About 45 vials were distributed in Ohio. The FDA has classified this recall as Class II.
The recall was initiated for lack of assurance of sterility.
Affected product is lot 240709 with an expiry date of 7/31/2026.
Patients and prescribers can identify affected product by the NDC, lot number and expiry date above, and may contact New Life Pharma LLC for further information.
The recalled product
- Product
- Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
- Manufacturer
- New Life Pharma LLC
- Category
- Drug — Injectable
- Hazard
- sterility-failure
- infection-risk
- injectable
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 240709
- exp 7/31/2026
Distribution
Distributed in 1 state:
- OH
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