FDA Recall
Terminated
Historical recordClass II
Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4
by High Performance Formulas, L.L.C. (HPF, L.L.C.)
- Reason
- Marketed Without an Approved NDA/ANDA
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19
by Novel Laboratories, Inc. d.b.a LUPIN
- Reason
- Failed Stability Specification; Out of specification for Osmolarity
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
by Noven Pharmaceuticals Inc
- Reason
- Failed Stability Specifications; out of specification for shear.
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
by Noven Pharmaceuticals Inc
- Reason
- Failed Stability Specifications; out of specification for shear.
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Mane Inc
- Product
- SWEET & SMOKY BBQ Packaged in 50lb kraft paper bags
- Reason
- Ingredient used in manufacturing tested positive for Salmonella
- Published
- August 25, 2021
- Distribution
- Distributed to Manufacturers located in:…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Mane Inc
- Product
- BBQ Seasoning Packaged in 50lb poly bag/cardboard box combo…
- Reason
- Ingredient used in manufacturing tested positive for Salmonella
- Published
- August 25, 2021
- Distribution
- Distributed to Manufacturers located in:…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Mane Inc
- Product
- Flavored Bacon Ranch Seasoning Packaged in 25lb kraft paper…
- Reason
- Ingredient used in manufacturing tested positive for Salmonella
- Published
- August 25, 2021
- Distribution
- Distributed to Manufacturers located in:…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cocanu LLC
- Product
- Moonwalk 70% dark chocolate bar. It is packaged in white sh…
- Reason
- Lactose is declared but milk is not declared on label.
- Published
- August 25, 2021
- Distribution
- Distributed in CA and OR.
View recall →
FDA Recall
Terminated
Historical recordClass II
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
by Aurobindo Pharma USA Inc.
- Reason
- Presence of Foreign Substance- Potential of metal contamination.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
McCormick & Company - MSS - HQ
- Product
- Frank s Red Hot Buffalo Ranch Seasoning 153g, Plastic Bottl…
- Reason
- Product may be contaminated with Salmonella.
- Published
- August 18, 2021
- Distribution
- The recalled product was distributed to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
McCormick & Company - MSS - HQ
- Product
- McCormick Culinary Italian Seasoning 1.75 lbs. , Plastic Jug…
- Reason
- Product may be contaminated with Salmonella.
- Published
- August 18, 2021
- Distribution
- The recalled product was distributed to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
McCormick & Company - MSS - HQ
- Product
- McCormick Perfect Pinch Italian Seasoning 1.31 oz. Plastic…
- Reason
- Product may be contaminated with Salmonella.
- Published
- August 18, 2021
- Distribution
- The recalled product was distributed to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods BABY NAPA KIMCHI in 128 oz, 64 oz, and 32 o…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods WHITE WHOLE KIMCHI in 128 oz, 64 oz, and 32…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods NO MSG JULRADO SLICED CABBAGE KIMCHI in 128…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods NO MSG JULRADO WHOLE CABBAGE KIMCHI in 128…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods NO MSG SLICED CABBAGE KIMCHI in 5GAL plasti…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- 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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