FDA Recall
Terminated
Historical recordClass II
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Published
- December 28, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 28, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Presence of foreign substance
- Published
- December 28, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Kerry Inc
- Product
- KERRY PRE IDQ 61-03 TND 50# 227262 300-121584, NET WEIGHT: 5…
- Reason
- The firm is recalling their flour based breading due to the presence of egg allergen which is not listed on the label.
- Published
- December 28, 2022
- Distribution
- Product was shipped to two customers in…
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FDA Recall
Terminated
Historical recordClass III
Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26
by Camber Pharmaceuticals, Inc
- Reason
- Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
- Published
- December 21, 2022
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.
by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
- Reason
- Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
- Published
- December 21, 2022
- Distribution
- BayCare Health System hospitals in FL
View recall →
FDA Recall
Terminated
Historical recordClass II
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
by Atlantic Management Resources Ltd.
- Reason
- cGMP Deviations
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.
by Atlantic Management Resources Ltd.
- Reason
- cGMP Deviations
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
by Atlantic Management Resources Ltd.
- Reason
- cGMP Deviations
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
by Atlantic Management Resources Ltd.
- Reason
- cGMP Deviations
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
St. Jean's Coast Mountain Resources Ltd. (dba) St. Jean's Ca
- Product
- Sardines in tomato sauce packed in cans labeled in part, "WI…
- Reason
- Canned sardines in tomato sauce recalled due to high levels of histamine.
- Published
- December 21, 2022
- Distribution
- Distributed wholesale to 148 retail cust…
View recall →
FDA Recall
Terminated
Historical recordClass II
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.
by RemedyRePack Inc.
- Reason
- Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
- Published
- December 14, 2022
- Distribution
- Product was distributed to two different…
View recall →
FDA Recall
Ongoing
Historical recordClass II
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Published
- December 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
SUBURBAN BREAD CO.
- Product
- Big Sky Chocolate Chunk Peanut Butter Chip Granola, Net Wt 1…
- Reason
- The product labeling does not list sub-ingredients which contains milk, not declared in the ingredients or contains statement.
- Published
- December 14, 2022
- Distribution
- Distributed to retail stores in Iowa and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
SUBURBAN BREAD CO.
- Product
- Big Sky Chocolate Chunk Granola, Net Wt 14oz; UPC 02503 0047…
- Reason
- The product labeling does not list sub-ingredients which contains milk, not declared in the ingredients or contains statement.
- Published
- December 14, 2022
- Distribution
- Distributed to retail stores in Iowa and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Weis Markets, Inc., Ice Cream Division
- Product
- Weis Quality Premium Ice Cream Sea Salt Caramel Ripple 1.5 Q…
- Reason
- Undeclared soy and coconut
- Published
- December 14, 2022
- Distribution
- Distributed to retail stores in Pennsylv…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Taylor Farms Northwest, LLC
- Product
- Taylor Farms Carrot - Celery Sticks, Refrigerated & Ready To…
- Reason
- Metal fragment. A piece of metal about 3/4 inch was found in retail package.
- Published
- December 14, 2022
- Distribution
- Distributed in Washington only.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Taylor Farms Northwest, LLC
- Product
- Taylor Farms Guacamole Tray - Large, Refrigerated & Ready To…
- Reason
- Metal fragment. A piece of metal about 3/4 inch was found in retail package.
- Published
- December 14, 2022
- Distribution
- Distributed in Washington only.
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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