FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Basil Garlic Polenta, San Gennaro brand, Pre-cooked Ready to…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Traditional Polenta, San Gennaro brand, Pre-cooked Ready to…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- White Polenta, San Gennaro brand, 12/16oz packages, UPC# 7-6…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Red & Black Quinoa Organic Polenta, Ancient Harvest brand, P…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Green Chili Cilantro Organic Polenta, Ancient Harvest brand,…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Sundried Tomato Organic Polenta, Ancient Harvest brand, Pre-…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Mushroom and Onion Organic Polenta, Frieda's brand, Pre-cook…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Basil Garlic Organic Polenta, Ancient Harvest brand, Pre-coo…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Traditional Organic Polenta, Ancient Harvest brand, Pre-cook…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Italian Herb Polenta, Melissa's brand, Shelf stable, 12/16…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Original Polenta, Melissa's brand, Shelf stable, 12/16 oz pa…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
San Gennaro Foods, Inc
- Product
- Sun-Dried Tomato Polenta, Melissa's brand, Shelf stable, 12/…
- Reason
- Date coding ink was being printed directly on the food contact surface of packaging, allowing the ink to be in direct contact with the product. The ink is not approved for food use.
- Published
- November 15, 2017
- Distribution
- CA, CO, FL, GA, IL, IN, MD, ME, MI, NJ,…
View recall →
FDA Recall
Terminated
Historical recordClass II
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.
by Teva Pharmaceuticals USA
- Reason
- Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 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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