Drug Recall
Terminated
Historical recordClass II
NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
by Specialty Medicine Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiated
- October 19, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
View recall →
Drug Recall
Terminated
Historical recordClass II
METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
by Specialty Medicine Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiated
- October 19, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
View recall →
Drug Recall
Terminated
Historical recordClass II
METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
by Specialty Medicine Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiated
- October 19, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
View recall →
Drug Recall
Terminated
Historical recordClass II
HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
by Specialty Medicine Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiated
- October 19, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
View recall →
Drug Recall
Terminated
Historical recordClass II
GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
by Specialty Medicine Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiated
- October 19, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
View recall →
Drug Recall
Terminated
Historical recordClass II
Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
by Specialty Medicine Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiated
- October 19, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
View recall →
Drug Recall
Terminated
Historical recordClass II
Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
by Specialty Medicine Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiated
- October 19, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
View recall →
Drug Recall
Terminated
Historical recordClass II
Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
by Specialty Medicine Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiated
- October 19, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
View recall →
Drug Recall
Terminated
Historical recordClass II
Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
by Specialty Medicine Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiated
- October 19, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
View recall →
Drug Recall
Terminated
Historical recordClass II
Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-557-09
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
- Recall initiated
- September 17, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass II
0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.
by B. Braun Medical Inc
- Reason
- Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
- Recall initiated
- November 27, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- Nationwide in the US and Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass II
Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-002-06, Cas No: 1115-70-4
by Betachem, Inc.
- Reason
- CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
- Recall initiated
- October 7, 2013
- Reported by FDA
- January 22, 2014
- Distribution
- MO
View recall →
Drug Recall
Terminated
Historical recordClass II
Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
by Compounding Centre At Blue Ridge
- Reason
- Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
- Recall initiated
- October 18, 2013
- Reported by FDA
- January 15, 2014
- Distribution
- NC
View recall →
Drug Recall
Terminated
Historical recordClass II
Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
by Compounding Centre At Blue Ridge
- Reason
- Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
- Recall initiated
- October 18, 2013
- Reported by FDA
- January 15, 2014
- Distribution
- NC
View recall →
Drug Recall
Terminated
Historical recordClass III
Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA
by Mutual Pharmaceutical Company, Inc.
- Reason
- Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
- Recall initiated
- February 27, 2013
- Reported by FDA
- January 15, 2014
- Distribution
- Nationwide and Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass III
Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07
by Mutual Pharmaceutical Company, Inc.
- Reason
- Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
- Recall initiated
- February 27, 2013
- Reported by FDA
- January 15, 2014
- Distribution
- Nationwide and Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass III
FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA
by Mutual Pharmaceutical Company, Inc.
- Reason
- Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
- Recall initiated
- February 27, 2013
- Reported by FDA
- January 15, 2014
- Distribution
- Nationwide and Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass II
Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
by Compounding Centre At Blue Ridge
- Reason
- Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
- Recall initiated
- October 18, 2013
- Reported by FDA
- January 15, 2014
- Distribution
- NC
View recall →
Drug Recall
Terminated
Historical recordClass II
Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
by Compounding Centre At Blue Ridge
- Reason
- Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
- Recall initiated
- October 18, 2013
- Reported by FDA
- January 15, 2014
- Distribution
- NC
View recall →
Drug Recall
Terminated
Historical recordClass II
PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
by Compounding Centre At Blue Ridge
- Reason
- Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
- Recall initiated
- October 18, 2013
- Reported by FDA
- January 15, 2014
- Distribution
- NC
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
