Class I - Dangerous
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
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Prescription Drugs
💊 Drugs • 12,141 recalls
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430
Glenmark Generics Inc., USA
Class I - Dangerous
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30 mL, b) Polidocanol 1% 30 mL, c) Polidocanol 2% 30 mL, d) Polidocanol 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
FVS Holdings, Inc. dba. Green Valley Drugs
Class I - Dangerous
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
FVS Holdings, Inc. dba. Green Valley Drugs
Class I - Dangerous
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
FVS Holdings, Inc. dba. Green Valley Drugs
Class I - Dangerous
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class I - Dangerous
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class I - Dangerous
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class I - Dangerous
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.
Physicians Total Care
Class I - Dangerous
Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).
Class I - Dangerous
Failed Impurities/Degradation Specifications: 3 month stability testing.
Class I - Dangerous
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class I - Dangerous
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Class I - Dangerous
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class I - Dangerous
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Class I - Dangerous
Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.
Class I - Dangerous
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
Hi-Tech Pharmacal Co.
Class I - Dangerous
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Class I - Dangerous
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.