FDA Recall
Terminated
Historical recordClass III
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
by Fresenius Kabi USA, LLC
- Reason
- Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
- Published
- April 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.
by Actavis Elizabeth LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.
by Actavis Elizabeth LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.
by Actavis Elizabeth LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.
by Actavis Elizabeth LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
by Jubilant Draximage Inc
- Reason
- Labeling: Label Error on Declared Strength
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.
by Apace KY LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
by Bio-pharm, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
by Meditech Laboratories, Inc
- Reason
- Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
by Meditech Laboratories, Inc
- Reason
- Lack of Assurance of Sterility: incomplete or missing data regarding production.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
by Meditech Laboratories, Inc
- Reason
- Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
by Meditech Laboratories, Inc
- Reason
- Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
by Meditech Laboratories, Inc
- Reason
- Lack of Assurance of Sterility: incomplete or missing data regarding production.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .
by Meditech Laboratories, Inc
- Reason
- Lack of Assurance of Sterility: incomplete or missing data regarding production.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
by Meditech Laboratories, Inc
- Reason
- Superpotent Drug: one ingredient was found to be above assay specification.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305
by Virtus Pharmaceuticals, Llc
- Reason
- Defective Delivery System: Product may contain leaking capsules.
- Published
- April 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18
by PFIZER INC
- Reason
- Labeling: Label Mix-Up
- Published
- April 6, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52
by Dr. Reddy's Laboratories, Inc.
- Reason
- Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
- Published
- April 6, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,
by Praxair Inc.
- Reason
- CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
- Published
- April 6, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
by Praxair Inc.
- Reason
- CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
- Published
- April 6, 2016
- 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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