FDA Recall
TerminatedTerminated: December 2, 2022Historical 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
TerminatedTerminated: October 18, 2023Historical 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
TerminatedTerminated: February 1, 2022Historical 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
TerminatedTerminated: February 1, 2022Historical 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
TerminatedTerminated: February 1, 2022Historical 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
TerminatedTerminated: February 1, 2022Historical 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
TerminatedTerminated: February 1, 2022Historical 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 →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 1, 2022Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods NO MSG WHOLE CABBAGE KIMCHI in 5GAL plastic…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 1, 2022Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods JULRADO SLICED CABBAGE KIMCHI in 5GAL plast…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 1, 2022Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods JULRADO WHOLE CABBAGE KIMCHI in 5GAL plasti…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 1, 2022Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods WHOLE CABBAGE KIMCHI in 5GAL plastic tubs,…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 1, 2022Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods SLICED CABBAGE KIMCHI in 5GAL plastic tubs,…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 10, 2021Historical recordClass I
Slayer Forever, LLC dba BUBS Naturals
- Product
- BUBS Naturals MCT OIL Powder, Medium Chain Triglycerides fro…
- Reason
- Firm was notified by supplier of Medium Chain Triglycerides (MCT) that it contained undeclared milk allergens.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass I
Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.com.
by Qikmoov LLC
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
- Published
- August 11, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56
by Pfizer Inc.
- Reason
- CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
- Published
- August 11, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.
by Pfizer Inc.
- Reason
- CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
- Published
- August 11, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56
by Pfizer Inc.
- Reason
- CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
- Published
- August 11, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 24, 2022Historical recordClass II
Avanti Frozen Foods
- Product
- Cooked, Peeled and Deveined, Tail-on, Shrimp. CENSEA, Froz…
- Reason
- Potential contamination with Salmonella in frozen cooked shrimp
- Published
- August 11, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 19, 2022Historical recordClass II
GIVE AND GO PREPARED FOODS (USA)
- Product
- The Worthy Crumb Assorted Large Muffins - Double Chocolate -…
- Reason
- May be contaminated with Listeria monocytogenes
- Published
- August 11, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 19, 2022Historical recordClass II
GIVE AND GO PREPARED FOODS (USA)
- Product
- The Worthy Crumb Assorted Large Muffins - Banana Nut - 3.6oz…
- Reason
- May be contaminated with Listeria monocytogenes
- Published
- August 11, 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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