FDA Recall
TerminatedTerminated: November 29, 2017Historical recordClass III
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
by Akorn, Inc.
- Reason
- Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
- Published
- November 25, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3201-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3292-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03.
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- 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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