Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greec...
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
D-0405-2026April 1, 2026Parsippany, NJ
Teva Pharmaceuticals USA, Inc
Class IIOngoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greec...
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
D-0404-2026April 1, 2026Parsippany, NJ
Teva Pharmaceuticals USA, Inc
Class IIOngoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greec...
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
D-0346-2026March 4, 2026Bhiwadi, N/A
Wizcure Pharmaa Private Limited
Class IIOngoing
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured...
Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
D-0347-2026March 4, 2026Bhiwadi, N/A
LEO PHARMA INC
Class IIOngoing
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manu...
Reason: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
D-0349-2026March 4, 2026Bhiwadi, N/A
Fresenius Kabi Compounding, LLC
Class IIOngoing
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Reason: Lack of Assurance of Sterility
D-0335-2026February 18, 2026Canton, MA
Fresenius Kabi Compounding, LLC
Class IIOngoing
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
Reason: Lack of Assurance of Sterility
D-0334-2026February 18, 2026Canton, MA
Fresenius Kabi Compounding, LLC
Class IIOngoing
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
Reason: Lack of Assurance of Sterility
D-0336-2026February 18, 2026Canton, MA
Fresenius Kabi Compounding, LLC
Class IIOngoing
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.