ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
USACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Recalling Firm: American Regent, Inc.
Reason for Recall / Hazard
TranslatedPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Product Description & Identification
TranslatedACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Additional Source Details
| Field | Value |
|---|---|
| City | Shirley |
| State | NY |
| Openfda › Nui › 1 | N0000175429 |
| Openfda › Nui › 2 | N0000175961 |
| Openfda › Nui › 3 | N0000008867 |
| Openfda › Nui › 4 | N0000175960 |
| Openfda › Nui › 5 | N0000175776 |
| Openfda › Nui › 6 | N0000175547 |
| Openfda › Upc › 1 | 0305177510032 |
| Openfda › Upc › 2 | 0305177604250 |
| Openfda › Upc › 3 | 0305177504253 |
| Openfda › Upc › 4 | 0305177610039 |
| Openfda › Unii | WYQ7N0BPYC |
| Openfda › Route | RESPIRATORY (INHALATION) |
| Openfda › Rxcui › 1 | 307718 |
| Openfda › Rxcui › 2 | 307719 |
| Openfda › Spl id | 2bcb9dd3-17f8-439e-a395-aa081c5cc4bf |
| Openfda › Brand name | ACETYLCYSTEINE |
| Openfda › Spl set id | f56b4087-db48-4fd7-84ec-9c927962b805 |
| Openfda › Package ndc › 1 | 0517-7504-25 |
| Openfda › Package ndc › 2 | 0517-7604-25 |
| Openfda › Package ndc › 3 | 0517-7510-03 |
| Openfda › Package ndc › 4 | 0517-7610-03 |
| Openfda › Package ndc › 5 | 0517-7630-03 |
| Openfda › Package ndc › 6 | 0517-7604-01 |
| Openfda › Product ndc › 1 | 0517-7504 |
| Openfda › Product ndc › 2 | 0517-7604 |
| Openfda › Product ndc › 3 | 0517-7510 |
| Openfda › Product ndc › 4 | 0517-7610 |
| Openfda › Product ndc › 5 | 0517-7630 |
| Openfda › Generic name | ACETYLCYSTEINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class pe › 1 | Decreased Respiratory Secretion Viscosity [PE] |
| Openfda › Pharm class pe › 2 | Increased Glutathione Concentration [PE] |
| Openfda › Substance name | ACETYLCYSTEINE |
| Openfda › Pharm class epc › 1 | Antidote [EPC] |
| Openfda › Pharm class epc › 2 | Antidote for Acetaminophen Overdose [EPC] |
| Openfda › Pharm class epc › 3 | Mucolytic [EPC] |
| Openfda › Pharm class moa | Reduction Activity [MoA] |
| Openfda › Manufacturer name | American Regent, Inc. |
| Openfda › Application number | ANDA072489 |
| Openfda › Is original packager | true |
| Event id | 99503 |
| Address 1 | 5 Ramsay Rd |
| Code info | Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027. |
| Postal code | 11967-4701 |
| Report date | 20260826 |
| Product type | Drugs |
| Product quantity | 169,200 vials |
| Reason for recall | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260724 |
| Initial firm notification | Press Release |
| Center classification date | 20260826 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b)...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Recalling FirmAmerican Regent, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the U.S
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🚨 SAFETY ALERT: American Regent, Inc. - ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Check if your household is affected: https://therecallfile.com/recalls/acetylcysteine-solution-usp-20-200-mg-ml-packaged-in-a-4-ml-vial-not-f/FDA-D-0797-2026
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