FDA Recall
Terminated
Historical recordClass II
Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Failed Dissolution Specifications
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
by Qualitest Pharmaceuticals
- Reason
- Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
by South Coast Specialty Compounding, Inc.
- Reason
- Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- Published
- September 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
Terminated
Historical recordClass II
Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
Terminated
Historical recordClass II
Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
View recall →
FDA Recall
Terminated
Historical recordClass II
Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
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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