FDA Recall
TerminatedTerminated: June 13, 2017Historical 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
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FDA Recall
TerminatedTerminated: June 13, 2017Historical 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
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FDA Recall
TerminatedTerminated: June 13, 2017Historical 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
TerminatedTerminated: June 13, 2017Historical 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
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FDA Recall
TerminatedTerminated: May 1, 2019Historical 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
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FDA Recall
TerminatedTerminated: May 2, 2019Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms Baby Romaine - 4oz package , The salad produc…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms Mixed Greens 4oz package , The salad products p…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms LEMON BASIL 0.75oz package , The salad product…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms Thai Basil 0.75oz package , The salad product…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms Baby Kale 3 oz. package , The salad products pa…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms Arugula (4 oz. and 8 oz. package) (4 oz. and 8…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms Spring Mix (4 oz. and 8 oz. package) , The sala…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms Spinach Blend (4 oz. package) , The salad produ…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms Baby Spinach (4 oz. package) The salad products…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 27, 2021Historical recordClass II
BrightFarms, Inc.: WDC Greenhouse LLC
- Product
- Bright Farms Basil (.75 oz. package) The salad products pack…
- Reason
- According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
- Published
- June 21, 2017
- Distribution
- Product was delivered to two distributio…
View recall →
FDA Recall
TerminatedTerminated: December 13, 2017Historical 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
TerminatedTerminated: September 24, 2021Historical 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 →
FDA Recall
TerminatedTerminated: September 24, 2021Historical recordClass II
Estradiol 10 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: 69761-010-01
by Qualgen
- Reason
- CGMP deviations- Lack of Quality Assurance
- Published
- June 14, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 24, 2021Historical recordClass II
Estradiol 12.5 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: 69761-012-01
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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