FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
Phenol, 6%, 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: May 11, 2016Historical 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
- Published
- January 22, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 1, 2014Historical 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).
- Published
- January 22, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 1, 2014Historical 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
- Published
- January 15, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 1, 2014Historical 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
- Published
- January 15, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 1, 2014Historical 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
- Published
- January 15, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 4, 2014Historical recordClass II
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
by Watson Laboratories Inc
- Reason
- Presence of Foreign Substance; metal particulates were visually observed in the tablets.
- Published
- January 15, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 27, 2014Historical recordClass II
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
by Teva Pharmaceuticals USA
- Reason
- Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
- Published
- January 8, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 10, 2014Historical recordClass II
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
by Hospira Inc.
- Reason
- Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
- Published
- January 8, 2014
- 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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