FDA Recall
Terminated
Historical recordClass II
RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048
by RIJ Pharmaceutical LLC
- Reason
- CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- Published
- June 20, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080
by RIJ Pharmaceutical LLC
- Reason
- CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- Published
- June 20, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357, NDC 53807-12612, UPC 53807126122
by RIJ Pharmaceutical LLC
- Reason
- CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- Published
- June 20, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC 353807158123
by RIJ Pharmaceutical LLC
- Reason
- CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- Published
- June 20, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Divvies LLC
- Product
- simply delicious Divvies SEMI-SWEET PEPPERMINT BARS made to…
- Reason
- Product may contain traces of milk.
- Published
- June 20, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL
by HOSPIRA INC, LAKE FOREST
- Reason
- Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
- Published
- June 13, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
by Pharmaceutical Associates Inc
- Reason
- Resuspension problems: Out of specification for appearance and resuspendability.
- Published
- June 13, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1
by Apotex Inc.
- Reason
- Presence of foreign substance: glass particles
- Published
- June 13, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dean Foods, Inc.
- Product
- Baskin Robbins Mint Chocolate Chip
- Reason
- Product may contain unlabeled coconut.
- Published
- June 13, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Heritage Short Bread, Inc.
- Product
- Heritage Shortbreaad Lemon Infused Ingredients: Enriched flo…
- Reason
- During a South Carolina State Department inspection the firm was notified that the label did not list wheat as an ingredient.
- Published
- June 13, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lake Michigan Distilling Co LLC
- Product
- Ethanol Extraction 190 Proof Non-Denatured Grain Alcohol, M…
- Reason
- Lake Michigan Distilling, LLC, dba Ethanol Extraction has initiated a voluntary recall of Ethanol Extraction s 190 Proof Non-Denatured Grain Alcohol due to contamination with methanol which could cause serious injury or death if consumed.
- Published
- June 13, 2018
- Distribution
- Domestic: AK, AL, AR, AZ, CA, CO, CT, DC…
View recall →
FDA Recall
Terminated
Historical recordClass I
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
by Shoreside Enterprises Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Published
- June 6, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
by Shoreside Enterprises Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Published
- June 6, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Liberty Snacks NUTS ALMOND RAISIN Mix Net Wt. 1.6 oz (#g) DI…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Liberty Snacks Raw ALMONDS Net Wt. 1.3 oz (#g) DISTRIBUTED B…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Liberty Snacks Honey Roasted CASHEWS Net Wt. 1.2 oz (#g) DIS…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Liberty Snacks Natural PISTACHIOS Net Wt. 1 oz (#g) DISTRIBU…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Hickory Harvest Island Fruit Mix NET WT 9 oz (255g) Distribu…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Heinens Organic Nut Mix Net Wt. 9 oz (255g) Distributed By H…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ziyad Brothers Importing, Inc.
- Product
- Ziyad Brand Tahini, 8oz, 16oz, ¿ gal, 32oz. , packed in glas…
- Reason
- Ziyad Brothers Importing is voluntarily recalling its Ziyad Brand Tahini, 8 oz. 16 oz., 1/2 gallon and 32 oz. sizes due to potential contamination with Salmonella.
- Published
- June 6, 2018
- Distribution
- Domestic: AL, AR, AZ, CA, CT, DE, FL, GA…
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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