FDA Recall
Terminated
Historical recordClass III
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
by Wockhardt Usa Inc.
- Reason
- Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
- Published
- December 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01
by Hospira Inc.
- Reason
- Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
- Published
- December 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960.
by Eisai Inc
- Reason
- Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
- Published
- December 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
- Published
- December 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21
by American Health Packaging
- Reason
- Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
- Published
- December 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
- Published
- December 24, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
by CareFusion 213, LLC
- Reason
- Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
- Published
- December 17, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
- Published
- December 17, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
- Published
- December 17, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
- Published
- December 17, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility; improperly crimped fliptop vials
- Published
- December 17, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
- Published
- December 17, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
by Fresenius Kabi USA, LLC
- Reason
- Defective Container: Vials may be missing stoppers.
- Published
- December 17, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
by Zydus Pharmaceuticals USA Inc
- Reason
- Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
- Published
- December 10, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
by Sandoz, Inc
- Reason
- Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
- Published
- December 10, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Published
- December 3, 2014
- 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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