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Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9 Class II

Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Omega & Delta Co., Inc. 20231020 Ongoing
Distributed: Distributed in Puerto Rico only.
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DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4 Class II

Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Omega & Delta Co., Inc. 20231020 Ongoing
Distributed: Distributed in Puerto Rico only.
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DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4 Class II

Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Omega & Delta Co., Inc. 20231020 Ongoing
Distributed: Distributed in Puerto Rico only.
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2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11 Class I

Reason: Presence of Particulate Matter: identified as glass.

Pfizer Inc. 20231002 Terminated
Distributed: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
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1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11 Class I

Reason: Presence of Particulate Matter: identified as glass.

Pfizer Inc. 20231002 Terminated
Distributed: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
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4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24 Class I

Reason: Presence of Particulate Matter: identified as glass.

Pfizer Inc. 20231002 Terminated
Distributed: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
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V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935 Class III

Reason: Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).

Grato Holdings, Inc. 20231030 Terminated
Distributed: Distributed to one direct account in Florida with possible further distribution out of state.
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Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01. Class II

Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Zydus Pharmaceuticals (USA) Inc 20231019 Completed
Distributed: Nationwide.
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Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01. Class II

Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Zydus Pharmaceuticals (USA) Inc 20231019 Completed
Distributed: Nationwide.
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Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01 Class II

Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Zydus Pharmaceuticals (USA) Inc 20231019 Completed
Distributed: Nationwide.
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