🍔 Food 💊 Drugs 🏥 Medical Devices
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440 Class II

Reason: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Aire-Master of America Inc 20220715 Terminated
Distributed: Florida, Illinois, Iowa, New Jersey
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Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253 Class II

Reason: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Aire-Master of America Inc 20220715 Terminated
Distributed: Florida, Illinois, Iowa, New Jersey
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Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253 Class II

Reason: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Aire-Master of America Inc 20220715 Terminated
Distributed: Florida, Illinois, Iowa, New Jersey
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Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01 Class II

Reason: cGMP Deviations: deviations leading to potential cross-contamination.

Nephron Sc Inc 20220810 Terminated
Distributed: USA Nationwide
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Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ Class III

Reason: Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

Akron Pharma, Inc. 20220804 Terminated
Distributed: Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
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Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ Class III

Reason: Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

Akron Pharma, Inc. 20220804 Terminated
Distributed: Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
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Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8. Class II

Reason: Failed Impurities/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc 20220715 Terminated
Distributed: Nationwide.
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Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56 Class III

Reason: Subpotent Drug

Amerisource Health Services LLC 20220727 Terminated
Distributed: Nationwide within the USA
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Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60 Class II

Reason: Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.

Baxter Healthcare Corporation 20220804 Terminated
Distributed: Nationwide in the USA
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PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34 Class II

Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Nephron Sterile Compounding Center LLC 20220810 Terminated
Distributed: Nationwide in the USA
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