fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road,...
Reason: Lack of assurance of sterility:
D-0017-2024October 11, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbr...
Reason: Lack of assurance of sterility:
D-0015-2024October 11, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-...
Reason: Lack of assurance of sterility:
D-0012-2024October 11, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
Reason: Lack of assurance of sterility:
D-0009-2024October 11, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
Reason: Lack of assurance of sterility:
D-0023-2024October 11, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
Reason: Lack of assurance of sterility:
D-0003-2024October 11, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-20...
Reason: Lack of assurance of sterility:
D-0027-2024October 11, 2023San Diego, CA
Sofie Co dba Sofie
Class IITerminated
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life...
Reason: Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
D-1177-2023October 4, 2023Sterling, VA
AMMAN PHARMACEUTICAL INDUSTRIES
Class IIOngoing
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15...
Reason: Lack of Assurance of Sterility
D-1167-2023September 27, 2023Amman
AMMAN PHARMACEUTICAL INDUSTRIES
Class IIOngoing
TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.
Reason: Lack of Assurance of Sterility
D-1154-2023September 27, 2023Amman
AMMAN PHARMACEUTICAL INDUSTRIES
Class IIOngoing
TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.
Reason: Lack of Assurance of Sterility
D-1165-2023September 27, 2023Amman
AMMAN PHARMACEUTICAL INDUSTRIES
Class IIOngoing
TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.
Reason: Lack of Assurance of Sterility
D-1158-2023September 27, 2023Amman
AMMAN PHARMACEUTICAL INDUSTRIES
Class IIOngoing
TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15.
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.