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,…
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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
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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
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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
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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
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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
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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
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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
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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
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FDA Recall
Terminated
Historical recordClass II
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014
by Kiriko, LLC.
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
- Published
- November 8, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
by Precision Dose Inc.
- Reason
- Subpotent Drug: low out of specification results.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.
by Sanofi-Aventis U.S. LLC
- Reason
- Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
- Published
- November 8, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
by AVKARE Inc.
- Reason
- Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Triple B Corporation
- Product
- Veggie Tray w/Dip (12"), Alaska Carrot brand, 2 x 32 oz. pe…
- Reason
- Veggie Tray w/Dip product is recalled due to possible contamination with Listeria monocytogenes. The broccoli used in processing this item has been recalled by vendor Mann Packing of Salinas, California.
- Published
- November 8, 2017
- Distribution
- distributed in Alaska, Idaho, Montana, O…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Triple B Corporation
- Product
- Veggie Medley, Alaska Carrot, 12 x 16 oz. per case, UPC 45…
- Reason
- Veggie Medley product is recalled due to possible contamination with Listeria monocytogenes. The broccoli used in processing this item has been recalled by vendor Mann Packing of Salinas, California.
- Published
- November 8, 2017
- Distribution
- distributed in Alaska, Idaho, Montana, O…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Triple B Corporation
- Product
- Broccoli Florette, Alaska Carrot brand, 1 x 3 lb. per case,…
- Reason
- Broccoli Florette product is recalled due to possible contamination with Listeria monocytogenes. The broccoli used in processing this item has been recalled by vendor Mann Packing of Salinas, California.
- Published
- November 8, 2017
- Distribution
- distributed in Alaska, Idaho, Montana, O…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Triple B Corporation
- Product
- Stir Fry (GL) 4 x 10 oz. per case, UPC 45009 85367 7. Stir…
- Reason
- Stir Fry product is recalled due to possible contamination with Listeria monocytogenes. The broccoli used in processing this item has been recalled by vendor Mann Packing of Salinas, California.
- Published
- November 8, 2017
- Distribution
- distributed in Alaska, Idaho, Montana, O…
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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