FDA Recall
Terminated
Historical recordClass I
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
- Published
- May 16, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- Published
- May 16, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- Published
- May 16, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply
by Kroger Specialty Pharmacy, Inc.
- Reason
- Lack of Processing Controls.
- Published
- May 16, 2018
- Distribution
- Multiple states
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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