FDA Drug Recalls

Class IIITerminated

Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and 2) FUL-GLO, individually wrapped strip (NDC 1748-403-03), barcode (01)00317478403036, packaged in 300-count strips per carton (NDC 17478-403-030, UPC 3 17478-403-03 6), Manufactured for: Akorn, Inc., Lake Forest, IL 60045.

Nomax Inc

Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.

March 24, 2015 · DrugView details →

MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30

Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16

Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16

Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25

C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414

Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20

Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90

GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.

Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)00351801004019, packaged in 100-count strips per carton (NDC 51801-004-40, UPC 3 51801 00440 8), Nomax, Inc., St. Louis, MO 63123 USA.

0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02

5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02

Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02

10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02