FDA Recall
Terminated
Historical recordClass II
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56
by Teva Pharmaceuticals USA
- Reason
- Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
- Published
- July 16, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10
by Fresenius Kabi USA, LLC
- Reason
- Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
- Published
- July 16, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02
by Fresenius Kabi USA, LLC
- Reason
- Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
- Published
- July 16, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
by Boehringer Ingelheim Roxane Inc
- Reason
- Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
- Published
- July 16, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3
by Ferring Pharmaceuticals Inc
- Reason
- Discoloration; due to prolonged heat exposure.
- Published
- July 16, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
- Published
- July 16, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20
by Hospira Inc.
- Reason
- Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
- Published
- July 16, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81.
by Caraco Pharmaceutical Laboratories, Ltd.
- Reason
- Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
- Published
- July 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
by West-Ward Pharmaceutical Corp.
- Reason
- Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
- Published
- July 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
- Published
- July 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
by Forest Pharmaceuticals Inc
- Reason
- Failed Dissolution Specifications: Drug failed stage III dissolution testing.
- Published
- July 9, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.
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.
- Published
- July 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
- Published
- July 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30
by Pfizer Us Pharmaceutical Group
- Reason
- 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.
- Published
- July 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
- Published
- July 2, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 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.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, 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.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 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.
- Published
- June 25, 2014
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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