FDA Recall
Terminated
Historical recordClass II
Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA
by Actavis South Atlantic LLC
- Reason
- Failed Impurity/Degradation Specification; "Related Compound C"
- Published
- August 7, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
by Green Planet Inc
- Reason
- Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.
- Published
- August 7, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton, Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1.
by Procter & Gamble Co
- Reason
- Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.
- Published
- August 7, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
by Warner Chilcott US LLC
- Reason
- Failed Impurities/Degradation Specifications: unspecified degradation product
- Published
- August 7, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
by West-Ward Pharmaceutical Corp.
- Reason
- Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724
by West-Ward Pharmaceutical Corp.
- Reason
- Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.
by Watson Laboratories Inc
- Reason
- Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.
by Astellas Pharma US Inc
- Reason
- Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,
by Alkermes, Inc.
- Reason
- Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
by Watson Laboratories, Inc.-(Actavis) - Florida
- Reason
- Failed Tablet/Capsule Specifications: Broken tablets
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
by Max Huber Research Labs, Inc.
- Reason
- Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
by Max Huber Research Labs, Inc.
- Reason
- Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
by Max Huber Research Labs, Inc.
- Reason
- Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5.
by Vi-Jon, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
by Med Prep Consulting, Inc.
- Reason
- Lack of Assurance of Sterility; potential for mold contamination
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
by Med Prep Consulting, Inc.
- Reason
- Non-Sterility; mold contamination
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA.
by Mobius Therapeutics LLC
- Reason
- Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821
by Pharmalucence, Inc.
- Reason
- Presence of Particulate Matter; particulate found in retain samples
- Published
- July 31, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
by Apotex Corp.
- Reason
- Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
- Published
- July 24, 2013
- 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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