Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
WHO, and other public sources. It is an independent information service, not a medical provider, and
not a substitute for professional medical advice or your local public health department's own guidance.
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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Showing 16,001–16,020 of 17,987 drug recalls
Drug RecallTerminatedHistorical recordClass II
EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, 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.
EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, 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.
DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, 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.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.
CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, 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.
Cyanocobalamin, 1000 mcg/ml; injectable, 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.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.
Ceftazidime, 22.5 mg/ml (ophthalmic), 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.
Aluminum Potassium Sulfate Sterile powder, 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.
Quinapril Tablets USP, 5 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 68180-556-09
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
Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.
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.
