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Filters
Showing 15,141–15,160 of 17,987 drug recalls
Drug RecallTerminatedHistorical recordClass II
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
by Brookfield Prescription Center Inc. dba MD Custom Rx
Reason
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
by Baxter Healthcare Corp.
Reason
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637.
by Bausch & Lomb, Inc.
Reason
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
by Caraco Pharmaceutical Laboratories, Ltd.
Reason
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203 615-327-3234
by John W Hollis Inc
Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
by John W Hollis Inc
Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
