Compounded Tirzepatide Vials Mislabeled with Testosterone Cypionate
Revive Rx Pharmacy recalls 751 vials of compounded tirzepatide (Lot #748127) labeled to contain tirzepatide but actually filled with testosterone cypionate. Patients receiving this medication may take the wrong drug with serious health consequences.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I classification applies due to the critical medication mix-up where patients expecting tirzepatide would receive testosterone cypionate instead. Although no illnesses or injuries are reported in the source text, the potential for serious harm from receiving an incorrect prescription medication is substantial and meets the agency's highest hazard classification.
Plain-English summary
Revive Rx Pharmacy in Houston, Texas is recalling 751 vials of tirzepatide 10 mg/0.5 mL sterile solution due to a critical labeling error. The affected product is supplied in two-milliliter multi-dose vials with Lot #748127, expiration date September 2024, and was distributed nationwide.
The vials are labeled as containing tirzepatide but actually contain testosterone cypionate, a different medication entirely. This labeling mix-up means patients expecting to receive tirzepatide will instead receive testosterone cypionate, a substantial medication error with potential for serious harm.
Patients who received vials from this lot should not use the product and should contact their healthcare provider or pharmacist immediately. Any person who has already self-administered doses should report any unusual symptoms to their doctor. All unused vials from this lot should be returned to the pharmacy.
The recalled product
- Product
- Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
- Manufacturer
- Revive Rx LLC dba Revive Rx Pharmacy
- Affected units
- 751
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 #: 748127
- Exp 9/24/2024
Distribution
Distributed nationwide across the United States.
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