Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-03-15FDA-DrugActavis IncClass IIILevofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
- 2017-03-15FDA-DrugMckesson Packaging ServicesClass IIAspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.
Presence of Foreign Substance: foreign material found in the bulk inventory.
- 2017-03-15FDA-DrugEndo Pharmaceuticals, Inc.Class IIEdex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
- 2017-03-15FDA-DrugTeva Pharmaceuticals USAClass IIIRisedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
- 2017-03-15FDA-DrugLEO PHARMA INCClass IICalcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
- 2017-03-15FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIMirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
- 2017-03-15FDA-DrugMylan Pharmaceuticals Inc.Class IIMirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
- 2017-03-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIZenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
Failed dissolution specifications - low dissolution results at S3 stage.
- 2017-03-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIZenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81
Failed dissolution specifications - low dissolution results at S3 stage.
- 2017-03-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIZenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
Failed dissolution specifications - low dissolution results at S3 stage.
- 2017-03-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIZenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81
Failed dissolution specifications - low dissolution results at S3 stage.
- 2017-03-08FDA-DrugPacific Medical SolutionsClass INano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
- 2017-03-08FDA-DrugL. Perrigo CompanyClass IIISalicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
- 2017-03-08FDA-DrugL. Perrigo CompanyClass IIISalicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
- 2017-03-08FDA-DrugSun Pharmaceutical Industries, Inc.Class IIAlfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
- 2017-03-08FDA-DrugG & W Laboratories, Inc.Class IIIndocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
- 2017-03-08FDA-DrugAllegiant HealthClass IIHealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729
cGMP deviations - presence of rubber particles found loose in the bulk product.
- 2017-03-08FDA-DrugUnited Exchange CorporationClass IIEYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
Lack of assurance of sterility
- 2017-03-08FDA-DrugUnited Exchange CorporationClass IIEye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828
Lack of assurance of sterility
- 2017-03-08FDA-DrugUnited Exchange CorporationClass IIEye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97
Lack of assurance of sterility
- 2017-03-08FDA-DrugUnited Exchange CorporationClass IEYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
- 2017-03-08FDA-DrugAbbVie Inc.Class IIDuopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
- 2017-03-08FDA-DrugJeffreys Drug StoreClass IDomperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
- 2017-03-08FDA-DrugMylan Pharmaceuticals Inc.Class IIglipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
- 2017-03-08FDA-DrugAmerisource Health ServicesClass IICycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
- 2017-03-01FDA-DrugSage Products IncClass IIIQ Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, Rx only, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013, Reorder #6306, UPC 6 18029 83041 8.
Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
- 2017-03-01FDA-DrugMOORE'S COMPOUNDING PHARMACYClass IILevothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX
Superpotent Drug and Subpotent Drug; potency failures obtained
- 2017-03-01FDA-DrugCherry Hill Sales Co.Class IIMakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-203-35
CGMP Deviations
- 2017-03-01FDA-DrugCherry Hill Sales Co.Class IIMakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-208-28
CGMP Deviations
- 2017-03-01FDA-DrugCherry Hill Sales Co.Class IIMakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E, Camphor-1% Menthol-1%, 1oz.(28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-201-28
CGMP Deviations
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