FDA Recall
Terminated
Historical recordClass III
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
by Teva Pharmaceuticals USA
- Reason
- Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
- Published
- March 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
by Breckenridge Pharmaceutical, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
- Published
- March 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
by Edge Pharma, LLC
- Reason
- Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
- Published
- March 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.
by Sagent Pharmaceuticals Inc
- Reason
- Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
- Published
- March 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Reason
- Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
- Published
- March 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA
by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Reason
- Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
- Published
- March 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
- Published
- March 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-3; Rx Only, Manufactured for Ferring Pharmaceuticals Inc. Parsippany. NJ 07054. Diluent manufactured for Ferring Pharmaceuticals Inc.
by Ferring Pharmaceuticals Inc
- Reason
- Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
- Published
- March 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)
by Teva Pharmaceuticals USA
- Reason
- Chemical contamination; Unknown brown residue adhering to the inside of one vial.
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: Out of specification for mechanical peel.
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: Out of specification for mechanical peel.
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: Out of specification for mechanical peel.
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: Out of specification for mechanical peel.
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Subpotent
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Ferrara Candy Company
- Product
- Ferrara Candy Company assorted candy Heart Box, including La…
- Reason
- Undeclared ingredients on retail packaging, including but not limited to certified colors Red #40 and Blue #1
- Published
- March 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631.
by Meitheal Pharmaceuticals Inc
- Reason
- Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
- Published
- March 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
- Published
- March 3, 2021
- 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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