🍔 Food 💊 Drugs 🏥 Medical Devices
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, 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. Class II

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

Caraco Pharmaceutical Laboratories, Ltd. 20140320 Terminated
Distributed: Nationwide and Puerto Rico
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0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04. Class II

Reason: Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.

Baxter Healthcare Corp. 20140421 Terminated
Distributed: nationwide
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Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5. Class II

Reason: Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Teva Pharmaceuticals USA 20140212 Terminated
Distributed: Nationwide and Puerto Rico
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Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. Class II

Reason: Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Teva Pharmaceuticals USA 20140212 Terminated
Distributed: Nationwide and Puerto Rico
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Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5. Class II

Reason: Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.

Legacy Pharmaceutical Packaging 20140214 Terminated
Distributed: Nationwide
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Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05. Class I

Reason: Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.

Hospira Inc. 20131223 Terminated
Distributed: Nationwide
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Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com. Class I

Reason: Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.

Deseo Rebajar 20131107 Terminated
Distributed: Nationwide and Puerto Rico
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Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11 Class I

Reason: Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

Baxter Healthcare Corp. 20140211 Terminated
Distributed: Nationwide.
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Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311 Class I

Reason: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc 20131121 Terminated
Distributed: Nationwide, Puerto Rico and Spain
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ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07 Class I

Reason: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc 20131121 Terminated
Distributed: Nationwide, Puerto Rico and Spain
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