🍔 Food 💊 Drugs 🏥 Medical Devices
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709 Class II

Reason: Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.

United Therapeutics Corp. 20140328 Terminated
Distributed: Fl, TX.
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BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53. Class II

Reason: Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.

Healix Infusion Therapy, Inc. 20140213 Terminated
Distributed: Texas
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HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Class II

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

Brookfield Prescription Center Inc. dba MD Custom Rx 20140530 Terminated
Distributed: WI only
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HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Class II

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

Brookfield Prescription Center Inc. dba MD Custom Rx 20140530 Terminated
Distributed: WI only
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HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Class II

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

Brookfield Prescription Center Inc. dba MD Custom Rx 20140530 Terminated
Distributed: WI only
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HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Class II

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

Brookfield Prescription Center Inc. dba MD Custom Rx 20140530 Terminated
Distributed: WI only
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Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Class II

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

Brookfield Prescription Center Inc. dba MD Custom Rx 20140530 Terminated
Distributed: WI only
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Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 Class II

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

Brookfield Prescription Center Inc. dba MD Custom Rx 20140530 Terminated
Distributed: WI only
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Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81. Class II

Reason: Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.

Caraco Pharmaceutical Laboratories, Ltd. 20140612 Terminated
Distributed: Nationwide including Puerto Rico
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Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. Class II

Reason: Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.

West-Ward Pharmaceutical Corp. 20140520 Terminated
Distributed: Nationwide
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