FDA Recall
Terminated
Historical recordClass II
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
by New England Life Care, Inc. dba Advanced Compounding Solutions
- Reason
- CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05
by New England Life Care, Inc. dba Advanced Compounding Solutions
- Reason
- CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
by New England Life Care, Inc. dba Advanced Compounding Solutions
- Reason
- CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10
by New England Life Care, Inc. dba Advanced Compounding Solutions
- Reason
- CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
by Ascend Laboratories, LLC
- Reason
- Failed Dissolution Specifications
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
by Dr Reddy's Laboratories Limited
- Reason
- Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Braga Fresh Foods
- Product
- 365 by Whole Foods Market Organic Asian Inspired Chopped Sal…
- Reason
- Undeclared milk and egg
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SunOpta Grains and Foods Inc.
- Product
- Seasons Choice Mixed Fruit, Strawberries, Pinneapple, Peache…
- Reason
- Fruit products have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SunOpta Grains and Foods Inc.
- Product
- Seasons Choice Tropical Blend, Pineapple, Mango, Strawberrie…
- Reason
- Fruit products have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SunOpta Grains and Foods Inc.
- Product
- Good & Gather Mixed Fruit Blend Pineapple Chunks, Sliced St…
- Reason
- Fruit products have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SunOpta Grains and Foods Inc.
- Product
- Trader Joe's Organic Tropical Fruit Blend, Pineapple, Banana…
- Reason
- Fruit products have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SunOpta Grains and Foods Inc.
- Product
- 365 Whole Foods Market Organic Tropical Fruit Medley. Straw…
- Reason
- Fruit products have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SunOpta Grains and Foods Inc.
- Product
- Good & Gather Mango Strawberry Blend. Whole Strawberries, M…
- Reason
- Fruit products have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SunOpta Grains and Foods Inc.
- Product
- Good & Gather Triple Berry Blend. Blueberries, Blackberries…
- Reason
- Fruit products have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SunOpta Grains and Foods Inc.
- Product
- 365 Whole Foods Market Organic Sliced Strawberries & Bananas…
- Reason
- Fruit products have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SunOpta Grains and Foods Inc.
- Product
- Great Value Mixed Fruit. Pineppple, Strawberries, Peaches a…
- Reason
- Fruit products have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 26, 2023
- 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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