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 →
FDA Recall
Terminated
Historical recordClass II
Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.
by AstraZeneca Pharmaceuticals LP
- Reason
- Defective Delivery System: Some units have actuation counters set to a number other than 60.
- Published
- March 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
by Sagent Pharmaceuticals Inc
- Reason
- Cross contamination with other products: metronidazole
- Published
- March 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61
by PharMEDium Services, LLC
- Reason
- Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
- Published
- March 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61
by PharMEDium Services, LLC
- Reason
- Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
- Published
- March 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
- Published
- March 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
by Teva Pharmaceuticals USA
- Reason
- Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
- Published
- March 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748
by Tf Supplements
- Reason
- Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
by Tf Supplements
- Reason
- Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77
by Golden State Medical Supply Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- March 16, 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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