FDA Recall
Terminated
Historical recordClass II
Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India.
by Lupin Pharmaceuticals Inc.
- Reason
- Superpotent Drug
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.
by Teligent Pharma, Inc.
- Reason
- Failed Stability Specifications: product did not meet viscosity results.
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10
by Macleods Pharma Usa Inc
- Reason
- Failed Impurities/Degradation Specifications
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Harris Teeter
- Product
- HARRIS TEETER FRESH FOODS MARKET 3 Layer COOKIES & CREME CAK…
- Reason
- The firm was notified by their contract manufacture that the product contains undeclared hazelnuts.
- Published
- April 21, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Starwest Botanicals, Inc
- Product
- Starwest Botanicals Item#: 209617-34, Item# 209617-31 Woo…
- Reason
- Presence of E. coli species
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
by X-Gen Pharmaceuticals Inc.
- Reason
- Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
by Cosette Pharmaceuticals, Inc.
- Reason
- CGMP Deviaitons
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30
by Alembic Pharmaceuticals Limited
- Reason
- Labeling: Label-mixup
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Moisture Limits: Out of specification for water content
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0
by Apotex Corp.
- Reason
- Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1
by Kimberly-Clark Corporation
- Reason
- Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Canteen Inc. dba MG Foods, Inc.
- Product
- MG Foods THE CLUB IN A SPINACH WRAP, Net Wt. 8.5oz (244g), M…
- Reason
- The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
- Published
- April 14, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Canteen Inc. dba MG Foods, Inc.
- Product
- MG Foods ROASTED TURKEY IN A TOMATO BASIL WRAP, Net Wt. 6.9o…
- Reason
- The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
- Published
- April 14, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Canteen Inc. dba MG Foods, Inc.
- Product
- FRESH TO YOU Deluxe Club Wrap, Net Wt. 10.39oz (295g), MG Fo…
- Reason
- The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
- Published
- April 14, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Canteen Inc. dba MG Foods, Inc.
- Product
- MG Foods TURKEY & SWISS ON A BUTTERY CROISSANT, Net Wt. 7.5o…
- Reason
- The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
- Published
- April 14, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Canteen Inc. dba MG Foods, Inc.
- Product
- MG Foods TURKEY & PROVOLONE ON 12 GRAIN WITH LETTUCE, TOMATO…
- Reason
- The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
- Published
- April 14, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Canteen Inc. dba MG Foods, Inc.
- Product
- MG Foods TURKEY & PROVOLONE BLT ON A BUTTERY CROISSANT, Net…
- Reason
- The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
- Published
- April 14, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Canteen Inc. dba MG Foods, Inc.
- Product
- MG Foods TURKEY & PEPPERJACK ROASTED TURKEY, PEPPERJACK, CHI…
- Reason
- The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
- Published
- April 14, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Canteen Inc. dba MG Foods, Inc.
- Product
- MG Foods TURKEY & CHEDDAR BLT ON TOASTED WHEAT BREAD, Net Wt…
- Reason
- The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
- Published
- April 14, 2021
- Distribution
- Product was shipped to the following sta…
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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