FDA Recall
TerminatedTerminated: May 1, 2019Historical recordClass II
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
by Intrathecal Compounding Specialist, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 14, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 1, 2019Historical recordClass II
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
by Intrathecal Compounding Specialist, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 14, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 1, 2019Historical recordClass II
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
by Intrathecal Compounding Specialist, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 14, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 1, 2019Historical recordClass II
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
by Intrathecal Compounding Specialist, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 3, 2020Historical recordClass III
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
by G & W Laboratories, Inc.
- Reason
- Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
- Published
- February 14, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
Panera, LLC
- Product
- Reduced-Fat Wild Blueberry Cream Cheese, 2 oz. and 8 oz.
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
Panera, LLC
- Product
- Panera Reduced-Fat Honey Walnut Cream Cheese, 2 oz. and 8 oz…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
Panera, LLC
- Product
- Panera Chive&Onion Reduced Fat Cream Cheese Spread, 2 oz. an…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 5, 2019Historical recordClass II
Ventura Foods Llc
- Product
- SunGlow, European Style Butter Blend Margarine, packaged in…
- Reason
- SunGlow contains undeclared soy lecithin.
- Published
- February 14, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 5, 2019Historical recordClass II
Ventura Foods Llc
- Product
- SunGlow, Unsalted European Style Butter Blend Margarine (169…
- Reason
- SunGlow contains undeclared soy lecithin.
- Published
- February 14, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 6, 2018Historical recordClass II
Simply Delicious, Inc. dba Bobo's Oat Bars
- Product
- Bobo's Coconut Oat Bar 3oz. Packaged in overwrap film per…
- Reason
- Bobo's recalled Coconut 3oz Bar due to mold.
- Published
- February 14, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
Panera, LLC
- Product
- Panera Reduced-Fat Plain Cream Cheese, 2 oz. and 8 oz.
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 12, 2018Historical recordClass I
Panera, LLC
- Product
- Panera Plain Cream Cheese, 2 oz. and 8 oz.
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2018Historical recordClass I
J F C International Inc
- Product
- Daisho Kimchi Hot Pot Soup Base; 1.60 lb pouch (10 units per…
- Reason
- Daisho Kimchi Hot Pot Soup base contains undeclared fish - shrimp and crab.
- Published
- February 14, 2018
- Distribution
- CA, NV, WA, OR, UT, AK, AZ, TX, OK, OH,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 21, 2018Historical recordClass II
CHOBANI
- Product
- Chobani Flip Key Lime Crumble - Key Lime Low-Fat Greek Yogur…
- Reason
- Product is recalled because a statement on the overwrap label erroneously states "No Gluten" while the ingredients statement and the Contains statements on both the overwrap label and the flip label on each individual cup declare wheat.
- Published
- February 14, 2018
- Distribution
- distributed in AL, AR, AZ, CA, CO, CT,…
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FDA Recall
TerminatedTerminated: August 29, 2018Historical recordClass I
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
by Baxter Healthcare Corporation
- Reason
- Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 7, 2020Historical recordClass I
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
by International Laboratories, LLC
- Reason
- LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 17, 2019Historical recordClass III
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
by Fresenius Kabi USA, LLC
- Reason
- Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2018Historical recordClass III
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2018Historical recordClass III
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 2018
- 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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