Drug recalls

Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-0…

Apothecary Pharma LLC · Lack of Assurance of Sterility

Class IIOngoingD-0036-2027
Status
Ongoing
City
Cary
State
NC
Country
United States
Classification
Class II
Product type
Drugs
Event ID
99952
Recalling firm
Apothecary Pharma LLC
Address 1
1913 Evans Rd
Address 2
N/A
Postal code
27513-2041
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States
Recall number
D-0036-2027
Product description
Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.
Product quantity
22 vials
Reason for recall
Lack of Assurance of Sterility
Recall initiation date
20260924
Center classification date
20261008
Report date
20261014
Code info

Lot #: AP-202622, BUD 07-Oct-2026; AP-202623, BUD 08-Oct-2026; AP-202624, BUD 19-Oct-2026; AP-202625, BUD 10/20/2026; AP-202627, BUD 10/26/2026; AP-202628, BUD 10/27/2026; AP-202629, BUD 10/28/2026; AP-202630, BUD 10/31/2026; AP-202631, BUD 11/01/2026; AP-202632, BUD 11/03/2026; AP-202633, BUD 11/07/2026; AP-202634, BUD 11/08/2026; AP-202635, BUD 11/16/2026; AP-202636, BUD 11/17/2026; AP-202637,BUD 11/18/2026; AP-202638, BUD 11/19/2026; AP-202639, BUD 11/20/2026; AP-202640, BUD 11/21/2026;AP-202641, BUD 11/22/2026; AP-202642, BUD 11/24/2026; AP-202643, BUD 11/25/2026; AP-202644, BUD 11/26/2026

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.