🍔 Food 💊 Drugs 🏥 Medical Devices
Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA. Class II

Reason: Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

Actavis Elizabeth LLC 20141215 Terminated
Distributed: Puerto Rico
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Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376. Class II

Reason: Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.

Right Value Drug Stores, Inc. 20141212 Terminated
Distributed: KS, MO, and TX.
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0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11 Class II

Reason: Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.

Hospira Inc. 20141222 Terminated
Distributed: Nationwide
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Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60). Class III

Reason: Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

Akorn, Inc. 20141209 Terminated
Distributed: Nationwide
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HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977 Class II

Reason: Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.

Par Pharmaceutical Inc. 20141124 Terminated
Distributed: Nationwide
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ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 Class III

Reason: Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

Qualitest Pharmaceuticals 20141222 Terminated
Distributed: Nationwide
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Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5. Class II

Reason: Failed Tablet/Capsule Specifications: Complaints of empty capsules received.

Aurobindo Pharma USA Inc 20141017 Terminated
Distributed: Nationwide
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GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY Class II

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

One and Zen 20141120 Terminated
Distributed: Nationwide
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Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN Class II

Reason: Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli

Tropichem Research Labs, Inc. 20141217 Terminated
Distributed: NY and IN.
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J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufactured for JayMac Pharmaceuticals, LLC, Sunset, LA; Manufactured by Sonar Products Inc., Carlstadt, NJ, NDC: 64661-032-30. Class II

Reason: Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.

Jaymac Pharmaceuticals L.L.C. 20141216 Terminated
Distributed: U.S. including: LA, AR, TX, MS
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