FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Ppushu Ppushu BBQ Flavor 3.17oz x 40ea Item #215030…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Ppushu Ppushu Grilled Chicken Flavor 3.17oz x 40ea…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Ppushu Ppushu Bulgogi Flavor 3.17oz x 40ea Item #21…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Spicy Seafood Flavor Udon Odongtong (Bowl) 3.53oz x…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Jjajang Bokki (Bowl) 4.23oz x 12ea Item #21502157…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Snack Ramen 5PK, Cup 1lb 3.05oz x 8pk, 2.18oz x 6ea…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Jin Ramen Spicy, Bowl, 5PK 4.23oz x 20ea, 3.88oz x 1…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Jin Ramen Mild Bowl, 5PK 3.88oz x 12ea, 1 lb 5.16oz…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Ramen Bokki (Cup) 4.23oz x 12ea Item #21309009 Man…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Yeul Ramen (Bowl) 4.06oz x 12ea Item #21305007 Man…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ottogi America Inc
- Product
- Ottogi Ramen Sari (Extra Noodle) 3.88oz x 48ea Item #21101…
- Reason
- Undeclared allergen; egg.
- Published
- March 6, 2019
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
Terminated
Historical recordClass III
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
by Akorn Inc
- Reason
- Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
by ACP Nimble Buyer, Inc.
- Reason
- Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
by Perrigo New York, Inc.
- Reason
- Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.
by Akorn Inc
- Reason
- Failed Stability Specification: out of specification results for Sodium Perborate
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
by ICU Medical Inc
- Reason
- CGMP Deviations
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
by US Compounding Inc
- Reason
- Lack of assurance of sterility.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications: Out of specification results observed for high dissolution.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 27, 2019
- 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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