FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
by Breckenridge Pharmaceutical, Inc
- Reason
- Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
by Pacific Healthcare, Inc dba B&B Pharmacy
- Reason
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Published
- November 18, 2015
- Distribution
- CA and NJ
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel)
by C. O. Truxton
- Reason
- Labeling: Wrong Bar Code
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
by Valeant Pharmaceuticals North America LLC
- Reason
- Failed Dissolution Specifications: Failed 24 month dissolution testing.
- Published
- November 11, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Reason
- Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
- Published
- November 11, 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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