Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
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Class II · Moderate risk Terminated
rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
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…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class I · High risk Terminated
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC#…
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class III · Low risk Terminated
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%…
Reason Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class III · Low risk Terminated
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use…
Reason Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class I · High risk Ongoing
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue…
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class I · High risk Ongoing
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash…
Reason Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Class III · Low risk Terminated
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only…
Reason Subpotent: Out of Specification result observed for low assay
Class III · Low risk Terminated
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%…
Reason Incorrect/Undeclared Excipients.
Class II · Moderate risk Terminated
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC…
Reason Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class II · Moderate risk Ongoing
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR…
Reason Lack of Assurance of Sterility