FDA Recall D-0655-2024
ProRx LLC · Exton, PA
Class II Ongoing 630 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0655-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-08-22
- Classified by FDA Center
- 2024-09-05
- FDA published
- 2024-09-11
- Recalling firm
- ProRx LLC
- Firm location
- Exton, PA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.