Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
D-0441-2026April 15, 2026Wichita, KS
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distribut...
Reason: Lack of Assurance of Sterility
D-0431-2026April 15, 2026Lake Zurich, IL
Fagron Compounding Services
Class IIOngoing
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
D-0442-2026April 15, 2026Wichita, KS
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 6...
Reason: Lack of Assurance of Sterility
D-0427-2026April 15, 2026Lake Zurich, IL
Fresenius Kabi USA, LLC
Class IIOngoing
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use N...
Reason: Lack of Assurance of Sterility
D-0424-2026April 15, 2026Lake Zurich, IL
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distribu...
Reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
D-0422-2026April 15, 2026Warren, NJ
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of U...
Reason: Lack of Assurance of Sterility
D-0432-2026April 15, 2026Lake Zurich, IL
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use ND...
Reason: Lack of Assurance of Sterility
D-0426-2026April 15, 2026Lake Zurich, IL
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 6...
Reason: Lack of Assurance of Sterility
D-0428-2026April 15, 2026Lake Zurich, IL
Fagron Compounding Services
Class IIOngoing
Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
D-0440-2026April 15, 2026Wichita, KS
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Dist...
Reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
D-0423-2026April 15, 2026Warren, NJ
Fresenius Kabi USA, LLC
Class IIOngoing
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-...
Reason: Lack of Assurance of Sterility
D-0435-2026April 15, 2026Lake Zurich, IL
Fagron Compounding Services
Class IIOngoing
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
D-0439-2026April 15, 2026Wichita, KS
Fresenius Kabi USA, LLC
Class IIOngoing
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-4...
Reason: Lack of Assurance of Sterility
D-0437-2026April 15, 2026Lake Zurich, IL
Fresenius Kabi USA, LLC
Class IIOngoing
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-...
Reason: Lack of Assurance of Sterility
D-0436-2026April 15, 2026Lake Zurich, IL
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical C...
Reason: Lack of Assurance of Sterility
D-0433-2026April 15, 2026Lake Zurich, IL
Preferred Pharmaceuticals, Inc.
Class IIOngoing
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0
Reason: Lack of Assurance of Sterility
D-0443-2026April 15, 2026Anaheim, CA
Fagron Compounding Services
Class IIOngoing
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
D-0438-2026April 15, 2026Wichita, KS
K.C. Pharmaceuticals, Inc
Class IIOngoing
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livoni...
Reason: Lack of Assurance of Sterility
D-0415-2026April 8, 2026Pomona, CA
K.C. Pharmaceuticals, Inc
Class IIOngoing
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70...
Reason: Lack of Assurance of Sterility
D-0416-2026April 8, 2026Pomona, CA
K.C. Pharmaceuticals, Inc
Class IIOngoing
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 7000...
Reason: Lack of Assurance of Sterility
D-0412-2026April 8, 2026Pomona, CA
K.C. Pharmaceuticals, Inc
Class IIOngoing
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoD...
Reason: Lack of Assurance of Sterility
D-0413-2026April 8, 2026Pomona, CA
K.C. Pharmaceuticals, Inc
Class IIOngoing
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701...