FDA Recall
Terminated
Historical recordClass I
Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]
by Sun Pharmaceutical Industries, Inc.
- Reason
- Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
- Published
- January 16, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- Published
- January 16, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- Published
- January 16, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- Published
- January 16, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- Published
- January 16, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
by Heritage Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
- Published
- January 16, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
- Published
- January 16, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Adam Bros. Farming, Inc.
- Product
- Adam Bros. Family Farms Cauliflower; Sold in cases with 9,…
- Reason
- Potential E. coli O157:H7 contamination.
- Published
- January 16, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Adam Bros. Farming, Inc.
- Product
- Adam Bros. Family Farms Green Leaf Lettuce; 24 heads per ca…
- Reason
- Potential E. coli O157:H7 contamination.
- Published
- January 16, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Adam Bros. Farming, Inc.
- Product
- Adam Bros. Family Farms Red Leaf Lettuce 24 heads per carto…
- Reason
- Potential E. coli O157:H7 contamination.
- Published
- January 16, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11.
by LUPIN SOMERSET
- Reason
- Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
- Published
- January 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Tropical Lime/Lime Tropicale 5.…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Sweet Kale/Chou Frise Doux: 5.5…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Raspberry Acai/Framboises ET: 5…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Avocado Ranch/Ranch et Avocats:…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Asian Sesame/Sesame Asiatique;…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sargento Foods, Inc.
- Product
- Frozen Unbreaded French onion / Swiss and Onion CC. Sample…
- Reason
- Sargento is recalling Frozen Unbreaded French Onion CC, Frozen Unbreaded Egg 3 cheese and caramelized Onion and Frozen Unbreaded Egg, Gouda, caramelized onion due to potential Listeria monocytogenes or Salmonella contamination.
- Published
- January 2, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sargento Foods, Inc.
- Product
- Frozen Unbreaded Egg, Gouda, caramelized onion. Sample Numb…
- Reason
- Sargento is recalling Frozen Unbreaded French Onion CC, Frozen Unbreaded Egg 3 cheese and caramelized Onion and Frozen Unbreaded Egg, Gouda, caramelized onion due to potential Listeria monocytogenes or Salmonella contamination.
- Published
- January 2, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sargento Foods, Inc.
- Product
- Frozen Unbreaded Egg, 3 Cheese and caramelized onion. Sampl…
- Reason
- Sargento is recalling Frozen Unbreaded French Onion CC, Frozen Unbreaded Egg 3 cheese and caramelized Onion and Frozen Unbreaded Egg, Gouda, caramelized onion due to potential Listeria monocytogenes or Salmonella contamination.
- Published
- January 2, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Moonstruck Chocolate Company
- Product
- Sea Salt Caramels Tumbled In Milk Chocolate, Moonstruck bran…
- Reason
- The Sea Salt Caramels Tumbled In Milk Chocolate is recalled due to a potential to be contaminated with hazelnuts and the finished label does not declare hazelnuts.
- Published
- January 2, 2019
- Distribution
- distributed in AZ, CA, ID, NH, NY, OR, T…
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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