FDA Recall
Terminated
Historical recordClass II
HealthA2Z 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
by Allegiant Health
- Reason
- cGMP deviations - presence of rubber particles found loose in the bulk product.
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
- Lack of assurance of sterility
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
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
Duopa (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
by AbbVie Inc.
- Reason
- 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
- Published
- March 8, 2017
- Distribution
- TN and IL
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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
🇺🇸 United States
Terminated
Historical recordClass I
Shearers Foods, Llc
- Product
- SPICY NACHO CHEESE TORTILLA CHIPS: Essential Everyday 10 oz…
- Reason
- The firm is recalling various snack products because they used ingredients received from Valley Milk Product which may be contaminated with Salmonella
- Published
- March 8, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Shearers Foods, Llc
- Product
- NACHO CHEESE TORTILLA CHIPS: Essential Everyday 1 oz bag (Mu…
- Reason
- The firm is recalling various snack products because they used ingredients received from Valley Milk Product which may be contaminated with Salmonella
- Published
- March 8, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Shearers Foods, Llc
- Product
- Larry The Cable Guy Jalapeno' Popper Thin Potato Chips 3 oz…
- Reason
- The firm is recalling various snack products because they used ingredients received from Valley Milk Product which may be contaminated with Salmonella
- Published
- March 8, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Shearers Foods, Llc
- Product
- Larry The Cable Guy Biscuits & Gravy Thin Potato Chips 3 oz…
- Reason
- The firm is recalling various snack products because they used ingredients received from Valley Milk Product which may be contaminated with Salmonella
- Published
- March 8, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Shearers Foods, Llc
- Product
- Delish Jalapeno' White Cheddar KETTLE COOKED FLAVORED POTATO…
- Reason
- The firm is recalling various snack products because they used ingredients received from Valley Milk Product which may be contaminated with Salmonella
- Published
- March 8, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Shearers Foods, Llc
- Product
- Deep River Sour Cream & Onion Krinkle Kettle Chips 2 oz bag…
- Reason
- The firm is recalling various snack products because they used ingredients received from Valley Milk Product which may be contaminated with Salmonella
- Published
- March 8, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ADM Milling Co.
- Product
- ADM Polar Bear Flour, Bleached/Enriched, NET WT 50LB
- Reason
- Product sample tested positive for salmonella.
- Published
- March 8, 2017
- Distribution
- IL and IN
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
MakeSense 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
by Cherry Hill Sales Co.
- Reason
- CGMP Deviations
- Published
- March 1, 2017
- Distribution
- Michigan, Illinois, New York, Florida, P…
View recall →
FDA Recall
Terminated
Historical recordClass II
MakeSense 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
by Cherry Hill Sales Co.
- Reason
- CGMP Deviations
- Published
- March 1, 2017
- Distribution
- Michigan, Illinois, New York, Florida, P…
View recall →
FDA Recall
Terminated
Historical recordClass II
MakeSense 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
by Cherry Hill Sales Co.
- Reason
- CGMP Deviations
- Published
- March 1, 2017
- Distribution
- Michigan, Illinois, New York, Florida, P…
View recall →
FDA Recall
Terminated
Historical recordClass II
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-210-28
by Cherry Hill Sales Co.
- Reason
- CGMP Deviations
- Published
- March 1, 2017
- Distribution
- Michigan, Illinois, New York, Florida, P…
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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