FDA Recall
Terminated
Historical recordClass II
Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941
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
GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087
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 APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161
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
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164
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 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
Morley Candy Makers, Inc.
- Product
- Milk Chocolate Covered Fudge Bites, 3.75oz, PET Pouch, 12 pa…
- Reason
- Morley Candy Makers, Inc. initiated a voluntary recall of Sanders Milk Chocolate Covered Fudge Bites due to undeclared allergen almonds (treenuts).
- Published
- June 20, 2018
- Distribution
- Domestic Only: CA, FL, IL, MI, NJ, OH, O…
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
🇺🇸 United States
Terminated
Historical recordClass II
R.A.B. Food Group LLC
- Product
- Manischewitz Brand, Dark Chocolate covered Potato Chips, 4.2…
- Reason
- The R.A.B. Food Group LLC dba The Manischewitz Company, 80 Avenue K, Newark, NJ 07105 has initiated a recall of Manischewitz Brand, Dark Chocolate covered Potato Chips, 4.25 oz. /12 per case. because of an undeclared allergen peanut, tree nut and milk.
- Published
- June 20, 2018
- Distribution
- Distribution states MD, PA, WA, CT, NY…
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
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
- Published
- June 13, 2018
- Distribution
- IN, MI, MS, NC, NJ, NY and OH
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 I
Desly International Corp.
- Product
- Melanie Mini Cookies with Caramel Flavor in a 17.6 oz (500g)…
- Reason
- Products contain undeclared peanuts.
- Published
- June 13, 2018
- Distribution
- CA CT FL GA IL KS KY MA MD ME…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Desly International Corp.
- Product
- Melanie Liubitelskie Cookies in a 17.6 oz (500g) clear plast…
- Reason
- Products contain undeclared peanuts.
- Published
- June 13, 2018
- Distribution
- CA CT FL GA IL KS KY MA MD ME…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GLOBAL COMMODITIES INC
- Product
- WATAN DRY FRUITS PREMIUM QUALITY NATURAL DRIED APRICOT WITH…
- Reason
- Product contains high levels of undeclared sulfites (2901 ppm).
- Published
- June 13, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
BLM Products U. Vertriebsges
- Product
- Priano Rosso Pesto Sauce, 6.7oz glass jar
- Reason
- BLM Prod.-und Vertriebsges.mbH & Co. KG has initiated a voluntary recall of Priano Rosso Pesto Sauce, 6.7 oz. packaged in glass jars due to undeclared allergens egg and milk.
- Published
- June 13, 2018
- Distribution
- Domestic only: Arkansas, California, Con…
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 →
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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