FDA Recall
TerminatedTerminated: September 22, 2014Historical 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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
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.
- Published
- January 22, 2014
- Distribution
- Hospitals, clinics, physicians, and pati…
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FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
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.
- 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, 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
- Published
- January 22, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 4, 2014Historical recordClass III
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.
by Novartis Consumer Health
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Published
- January 22, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 4, 2014Historical recordClass III
Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.
by Novartis Consumer Health
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Published
- January 22, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 5, 2015Historical recordClass II
Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8
by Greenstone Llc
- Reason
- 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.
- Published
- January 22, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 21, 2015Historical recordClass I
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
- Published
- January 22, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 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
0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, 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
Calcium Chloride* PF 500 mg/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
TROPICAMIDE* 1% OPHTHALMIC SOLUTION, 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
TRANEXAMIC ACID* 2 g/75 mL SOLUTION, 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
TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 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
Sodium tetradecyl SO4, 3% 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…
View recall →
FDA Recall
TerminatedTerminated: September 22, 2014Historical recordClass II
QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, prostaglandin, atropine sulfate), 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…
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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