Is N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 recalled?

Critical RiskFDA Drug

Unique Pharmaceutical, Ltd: Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.; Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.

Agency Publication Date: October 9, 2014

Affected Products

Product: N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133

Lot #: 86513, Exp 07/23/2014

Lot Numbers:

86513

Product: All sterile products within expiry

All Lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 68841

Status: Resolved

Manufacturer: Unique Pharmaceutical, Ltd

Manufactured In: United States

Units Affected: 2 products (3,529 Vials; 325,225 units (syringes, vials, bags))

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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