FDA DrugsClass II
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single d...
Published: April 15, 2026Recall ID: D-0423-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Warren |
| State | NJ |
| Openfda › Unii | IEU56G3J9C |
| Openfda › Route | SUBCUTANEOUS |
| Openfda › Rxcui › 1 | 749811 |
| Openfda › Rxcui › 2 | 749814 |
| Openfda › Rxcui › 3 | 749817 |
| Openfda › Spl id | 6d47aa22-362a-4663-8b98-a16c4ff0607a |
| Openfda › Brand name | LANREOTIDE ACETATE |
| Openfda › Spl set id | 2892b4c3-0329-4d29-97ff-3b45283bbab1 |
| Openfda › Package ndc › 1 | 69097-907-67 |
| Openfda › Package ndc › 2 | 69097-908-67 |
| Openfda › Package ndc › 3 | 69097-906-67 |
| Openfda › Product ndc › 1 | 69097-906 |
| Openfda › Product ndc › 2 | 69097-907 |
| Openfda › Product ndc › 3 | 69097-908 |
| Openfda › Generic name | LANREOTIDE ACETATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | LANREOTIDE ACETATE |
| Openfda › Manufacturer name | Cipla USA Inc. |
| Openfda › Application number | ANDA217193 |
| Openfda › Is original packager | true |
| Event id | 98575 |
| Address 1 | 10 Independence Blvd |
| Code info | Lot, expiry: 4401699IR1, Exp. 5/31/2026; 4401699IR2, Exp. 5/31/2026; 4401700IR1, Exp. 5/31/2026; 4401701IR1, Exp. 5/31/2026; 4401702IR1, Exp. 5/31/2026; 4401722IR1, Exp. 5/31/2026; 4401723IR1, Exp. 5/31/2026; 4401724IR1, Exp. 5/31/2026; 4401725IR1, Exp. 5/31/2026; 4401732IR1, Exp. 5/31/2026; 4401768IR1, Exp. 6/30/2026 4401769IR1, Exp. 11/30/2026; 4401787IR1, Exp. 11/30/2026; 4401815IR1, Exp. 11/30/2026; 4401816IR1, Exp. 11/30/2026; 4401834IR1, Exp. 11/30/2026; 4401835IR1, Exp. 11/30/2026; 4401846IR1, Exp. 11/30/2026; 4401851IR1, Exp. 11/30/2026; 4500017IR1, Exp. 12/31/2026; 4500031IR1, Exp. 12/31/2026; 4500032IR1, Exp. 12/31/2026; 4500033IR1, Exp. 12/31/2026; 4500076IR1, Exp. 1/31/2027; 4500117IR1, Exp. 2/28/2027; 4500118IR1, Exp. 2/28/2027; 4500173IR1, Exp. 4/31/2027; 4500270IR1, Exp. 2/28/2027; 4500271IR1, Exp. 2/28/2027; 4500273IR1, Exp. 2/28/2027; 4500312IR1, Exp. 2/28/2027; 4500313IR1, Exp. 3/31/2027; 4500350IR1, Exp. 3/31/2027; 4500351IR1, Exp. 3... [TRUNCATED] |
| Postal code | 07059-2730 |
| Report date | 20260415 |
| Product type | Drugs |
| Reason for recall | Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260313 |
| Initial firm notification | Letter |
| Center classification date | 20260403 |
Overview
- Recalling FirmCipla USA, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA