🍔 Food 💊 Drugs 🏥 Medical Devices
BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Class II

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Pallimed Solutions 20130325 Terminated
Distributed: Nationwide
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Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Class II

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Pallimed Solutions 20130325 Terminated
Distributed: Nationwide
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Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Class II

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Pallimed Solutions 20130325 Terminated
Distributed: Nationwide
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Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Class II

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Pallimed Solutions 20130325 Terminated
Distributed: Nationwide
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Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA Class II

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Pallimed Solutions 20130325 Terminated
Distributed: Nationwide
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Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01 Class II

Reason: Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.

American Health Packaging 20130521 Terminated
Distributed: Nationwide.
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BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6. Class III

Reason: Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

Actavis Inc 20130731 Terminated
Distributed: Nationwide and Puerto Rico
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Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36 Class III

Reason: Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card

Sandoz Incorporated 20130807 Terminated
Distributed: Nationwide
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Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724. Class II

Reason: Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.

West-Ward Pharmaceutical Corp. 20130730 Terminated
Distributed: Nationwide
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Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4. Class II

Reason: Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.

Apotex Inc 20130625 Terminated
Distributed: Nationwide
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