Lanreotide Injection, 120 Mg/0.5 Ml, Box Contains 1 Pre-filled Syringe, Single Dose Only, Rx Only, Manufactured By: Pharmathen International, S.a., Rodopi, Greece. Manufactured For: Cipla Usa, Inc.,
- Recalling firm
- Cipla USA, Inc.
- Product
- Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67
- Reason
- Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-13
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/45415e82-a0a4-4674-b09b-4cb457873b8f