FDARecalled Apr 15, 2026 · #D-0422-2026
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufacture...
Hazard
Class II — temporary health risk
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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 Distribution: Nationwide in the USA
Product details
- Product
- Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, 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: 69097-870-67
- Type
- Drugs
- Manufacturer
- Cipla USA, Inc.
- Model numbers
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- UPCs
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