FDA Recall
Terminated
Historical recordClass II
Eye 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
by United Exchange Corporation
- Reason
- Lack of assurance of sterility
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Eye 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
by United Exchange Corporation
- Reason
- Lack of assurance of sterility
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
EYE 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
by United Exchange Corporation
- Reason
- Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
by Amerisource Health Services
- Reason
- Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Q 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.
by Sage Products Inc
- Reason
- 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.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
by Hospira Inc., A Pfizer Company
- Reason
- Lack of Sterility Assurance: customer report of leaking bag
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
by Apotex Inc.
- Reason
- Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Falafel King Ent, Inc.
- Product
- Falafel King Tzatziki Sauce. 10 ounce. Plastic container
- Reason
- Falafel King announced a recall for their Tzatziki Sauce due to undeclared milk on product label.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Hostess Brands, LLC
- Product
- Holiday White Peppermint Hostess Twinkies, cream-filled snac…
- Reason
- Product contains an ingredient that was recalled by a supplier because it may be contaminated with Salmonella.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
by ACCORD HEALTHCARE, INC.
- Reason
- Failed tablet/capsule specification: missing break line on the 5mg tablet.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.
by LEO PHARMA INC
- Reason
- Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
by Actavis Inc
- Reason
- Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30
by Aurobindo Pharma USA Inc
- Reason
- Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
NOW Foods
- Product
- NOW¿ Multi-Food 1 Tablets, One Tablet Daily, 90 tablets, A D…
- Reason
- Product's supplement fact panel incorrectly states that the product contains 75 mg (milligrams) of Molybdenum, when it actually contains 75 mcg (micrograms).
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Two Little Guys Company
- Product
- Joe Chips Retro Potato Chips Sour Cream & Toasted Onion Di…
- Reason
- Joe Chips Sour Cream & Toasted Onion Retro Potato Chips contains a seasoning with a milk powder ingredient that may be contaminated with Salmonella although firm testing has not revealed the presence of the bacteria.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
by Apotex Inc.
- Reason
- Superpotent Drug: Product may not meet specifications throughout shelf life.
- Published
- February 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
by Aurobindo Pharma USA Inc
- Reason
- Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
- Published
- February 15, 2017
- 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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