FDA Recall
Terminated
Historical recordClass II
Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ
by Beamonstar Products
- Reason
- Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
- Published
- September 11, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ
by Beamonstar Products
- Reason
- Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
- Published
- September 11, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
by Teva Pharmaceuticals USA, Inc.
- Reason
- Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
- Published
- September 11, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12
by Hospira Inc.
- Reason
- Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
- Published
- September 4, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02
by Nexus Pharmaceuticals Inc
- Reason
- Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
- Published
- September 4, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
- Published
- September 4, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada, 66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3.
by Novocol Pharmaceutical of Canada
- Reason
- Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.
- Published
- September 4, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
by Hospira Inc.
- Reason
- Presence of Particulate Matter; product may contain fibrous material
- Published
- September 4, 2013
- 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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