🍔 Food 💊 Drugs 🏥 Medical Devices
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15 Class II

Reason: Microbial contamination of non-sterile product.

Grato Holdings, Inc. 20220524 Terminated
Distributed: Nationwide within the USA
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Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15 Class II

Reason: Microbial contamination of non-sterile product.

Grato Holdings, Inc. 20220524 Terminated
Distributed: Nationwide within the USA
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Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3 Class II

Reason: Microbial contamination of non-sterile product.

Grato Holdings, Inc. 20220524 Terminated
Distributed: Nationwide within the USA
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Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01 Class III

Reason: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

Teva Pharmaceuticals USA Inc 20220518 Terminated
Distributed: Product was distributed nationwide in the US Market
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B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523 Class II

Reason: Lack of Assurance of Sterility

US Specialty Formulations LLC 20220524 Terminated
Distributed: Product was distributed to medical facilities and a physician's office Nationwide in the USA.
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Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229 Class II

Reason: Lack of Assurance of Sterility

US Specialty Formulations LLC 20220524 Terminated
Distributed: Product was distributed to medical facilities and a physician's office Nationwide in the USA.
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Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. Class III

Reason: Failed Impurities/Degradation Specifications.

Novartis Pharmaceuticals Corporation 20220510 Terminated
Distributed: Nationwide within the United States
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