FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Blue Diamond Growers
- Product
- Blue Diamond Almonds Blanc DCD FN C (blanched diced fine);…
- Reason
- Firm was notified by customer of a positive Salmonella result obtained when testing of the product on receipt.
- Published
- June 28, 2017
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Genetic Edge Compounds LLC
- Product
- GEC TNT Thermanite 60 Capsules Dietary Supplement in clear p…
- Reason
- Product contains DMAA and Methylsynephrine.
- Published
- June 28, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
H & C Food Inc
- Product
- Master Carton is Labeled As: LOBSTER FLAVORED BALL DISTRIBUT…
- Reason
- Product may contain undeclared egg,
- Published
- June 28, 2017
- Distribution
- NY
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Joseph Shalhoub & Son, Inc.
- Product
- joray fruit roll FRUIT PUNCH flavor NET WT 1 OZ. (28g).…
- Reason
- Product contains undeclared wheat.
- Published
- June 28, 2017
- Distribution
- NY and FL
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
Terminated
Historical recordClass II
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
by American Pharmaceutical Ingredients LLC
- Reason
- cGMP Deviations; lack of quality assurance.
- Published
- June 21, 2017
- Distribution
- Multiple states
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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
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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
Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
by Safecor Health, LLC
- Reason
- CGMP Deviations
- Published
- June 21, 2017
- Distribution
- MA and NY
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205
by Safecor Health, LLC
- Reason
- CGMP Deviations
- Published
- June 21, 2017
- Distribution
- MA and NY
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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