🍔 Food 💊 Drugs 🏥 Medical Devices
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01, Class II

Reason: Subpotent; Hydrochlorothiazide at the 9 month time point.

Sandoz Inc 20131011 Terminated
Distributed: Nationwide
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Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial) Class II

Reason: Presence of Precipitate; precipitation of drug product

Teva Pharmaceuticals USA 20131011 Terminated
Distributed: Nationwide
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G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080 Class III

Reason: Failed Content Uniformity Specifications; at the 18 month time point.

G & W Laboratories Inc 20130930 Terminated
Distributed: Nationwide
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Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count bottle: NDC: 54686-0816-3. Class II

Reason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.

Physicians Total Care, Inc. 20131122 Terminated
Distributed: CA, GA, NC, and MO
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Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16. Class III

Reason: Failed Stability Specification; product viscosity and or pH are below specification.

Hi-Tech Pharmacal Co., Inc. 20131028 Terminated
Distributed: Nationwide
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Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07. Class II

Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

GlaxoSmithKline, LLC. 20131106 Terminated
Distributed: Nationwide
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Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00 Class II

Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

GlaxoSmithKline, LLC. 20131106 Terminated
Distributed: Nationwide
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Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009 Class II

Reason: Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.

Airgas Medical Services 20131010 Terminated
Distributed: To medical facilities in New Hampshire, Vermont, Massachusetts, and New York.
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Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09 Class II

Reason: Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.

Amedra Pharmaceuticals LLC 20131007 Terminated
Distributed: Nationwide
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Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691 Class II

Reason: Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.

Tower Pharmacy and Compounding 20131116 Terminated
Distributed: CA
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