🍔 Food 💊 Drugs 🏥 Medical Devices
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India. Class III

Reason: Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

SUN PHARMACEUTICAL INDUSTRIES INC 20230705 Terminated
Distributed: USA nationwide.
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Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10 Class II

Reason: Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Dr Reddy's Laboratories Limited 20230621 Ongoing
Distributed: Nationwide in the USA
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Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60 Class I

Reason: Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

Cipla USA, Inc. 20230627 Terminated
Distributed: Nationwide in the US
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Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15. Class II

Reason: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Global Pharma Healthcare Private Limited 20230130 Ongoing
Distributed: Product was distributed to two distributors who further distributed Nationwide in the USA.
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Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15. Class I

Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Global Pharma Healthcare Private Limited 20230130 Ongoing
Distributed: Product was distributed to two distributors who further distributed Nationwide in the USA.
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Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15. Class II

Reason: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Global Pharma Healthcare Private Limited 20230130 Ongoing
Distributed: Product was distributed to two distributors who further distributed Nationwide in the USA.
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Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15. Class I

Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Global Pharma Healthcare Private Limited 20230130 Ongoing
Distributed: Product was distributed to two distributors who further distributed Nationwide in the USA.
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Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67. Class II

Reason: Presence of Particulate Matter: Particulate matter identified as fiber.

Accord Healthcare, Inc. 20230703 Terminated
Distributed: Nationwide within the United States
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Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43. Class II

Reason: Presence of Particulate Matter: Particulate matter identified as fiber.

Accord Healthcare, Inc. 20230703 Terminated
Distributed: Nationwide within the United States
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0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00 Class II

Reason: Lack of assurance of sterility: bags have the potential to leak.

B. Braun Medical Inc. 20230705 Terminated
Distributed: USA Nationwide
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