FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Meijer, Inc #816 - Grand River Packaging
- Product
- Meijer Honey Vanilla Bourbon Pecans, 8.5 oz., 6/case, packed…
- Reason
- The firm initiated a voluntary recall of Meijer Honey Vanilla Bourbon Pecans, 8.5 oz., packed in a stand up pouch, due to mislabeling. The label declared cream, milk, and eggs, which were not part of the original formula. The label lacked the following ingredients: Spices, Artificial Flavors, Garlic Powder, Onion Powder, Dextrose, Worcestershire Sauce, Corn Syrup, Salt, Carmel Color, Sugar, Tamarind, Natural Flavor, Malic Acid, Olive Oil, Molasses Sucralose, Bourbon Whiskey, Sulfites & Celery Seeds.
- Published
- June 28, 2017
- Distribution
- Domestic: IL, IN, KY, MI, OH, WI,…
View recall →
FDA Recall
Terminated
Historical recordClass III
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
by Complete Pharmacy and Medical Solutions LLC
- Reason
- Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7.
by Bausch & Lomb, Inc.
- Reason
- CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04
by Hospira Inc., A Pfizer Company
- Reason
- GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
- Published
- June 21, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Woodland Foods
- Product
- D'Allesandro Woodland Foods De-stemmed Birdseye Chiles 1,…
- Reason
- Trace amounts of undeclared peanut found in product
- Published
- June 21, 2017
- Distribution
- OK, TX, WI, NJ, FL, WA, NY, LA, SD, IL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
General Mills, Inc
- Product
- Chocolate chip cookie dough larabars, 10 count , UPC 100-219…
- Reason
- Chocolate chip cookie dough larabars which contain cashews were incorrectly packaged in peanut butter cookie larabars boxes. The individual labeling on the chocolate chip cookie dough larabars is correct despite being in the wrong boxes.
- Published
- June 21, 2017
- Distribution
- MN, WI AL, AZ, CA, CO, GA, IA,IN, KS,…
View recall →
FDA Recall
Terminated
Historical recordClass III
Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01
by Hetero USA Inc
- Reason
- Presence of Foreign Substance: human hair melded into tablet.
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.
by Qualgen
- Reason
- CGMP deviations- Lack of Quality Assurance
- Published
- June 14, 2017
- 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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