FDA DrugsClass II
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 sa...
Published: April 15, 2026Recall ID: D-0422-2026Category: 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 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
Affected Products
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
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 | fd205110-15eb-4707-82b2-185e5bbf616b |
| Openfda › Brand name | LANREOTIDE ACETATE |
| Openfda › Spl set id | 11da176a-99bc-4ada-8b3f-6bd2b37a6313 |
| Openfda › Package ndc › 1 | 69097-880-67 |
| Openfda › Package ndc › 2 | 69097-890-67 |
| Openfda › Package ndc › 3 | 69097-870-67 |
| Openfda › Product ndc › 1 | 69097-870 |
| Openfda › Product ndc › 2 | 69097-880 |
| Openfda › Product ndc › 3 | 69097-890 |
| 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 | NDA215395 |
| Openfda › Is original packager | true |
| Event id | 98575 |
| Address 1 | 10 Independence Blvd |
| Code info | Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1, Exp 10/31/2027; 4401805IR1, Exp 10/31/2027; 4401824IR1, Exp 10/31/2027; 4401860IR1, Exp 10/31/2027; 4500019IR1, Exp 11/30/2027; 4500035IR1, Exp 11/30/2027; 4500036IR1, Exp 11/30/2027; 4500078IR1, Exp 11/30/2027; 4500079IR1, Exp 11/30/2027; 4500102IR1, Exp 12/31/2027; 4500119IR1, Exp 12/31/2027; 4500120IR1, Exp 12/31/2027; 4500121IR1, Exp 12/31/2027; 4500268IR1, Exp 1/31/2028; 4500269IR1, Exp 1/31/2028; 4500272IR1, Exp 1/31/2028; 4500314IR2, EXP 1/31/2028; 4500314RIR, EXP 1/31/2028; 4500315IR1, Exp 2/28/2028; 4500352IR1, Exp 2/28/2028; 4500353IR1, Exp 2/28/2028; 4500354IR1, Exp 2/28/2028; 4500355IR1, Exp 2/28/2028; 4500408IR1, Exp 2/28/2028; ... [TRUNCATED] |
| Postal code | 07059-2730 |
| Report date | 20260415 |
| Product type | Drugs |
| Product quantity | 54,583 syringes |
| 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