TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01
USTERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01
Recalling Firm: Blaine Labs Inc
Reason for Recall / Hazard
TranslatedCGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product Description & Identification
TranslatedTERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01
Additional Source Details
| Field | Value |
|---|---|
| City | Santa Fe Springs |
| State | CA |
| Openfda › Unii | K3D86KJ24N |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui › 1 | 998329 |
| Openfda › Rxcui › 2 | 2745978 |
| Openfda › Spl id | 92f83cae-7224-46f8-a9ac-550118c21f29 |
| Openfda › Brand name | TERPENICOL |
| Openfda › Spl set id | a020334e-aac9-4ea5-a0ea-8e5b021fe2eb |
| Openfda › Package ndc | 63347-600-01 |
| Openfda › Product ndc | 63347-600 |
| Openfda › Generic name | UNDECYLENIC ACID |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | UNDECYLENIC ACID |
| Openfda › Manufacturer name | Blaine Labs Inc. |
| Openfda › Application number | M005 |
| Openfda › Is original packager | true |
| Event id | 98731 |
| Address 1 | 11037 Lockport Pl |
| Address 2 | N/A |
| Code info | Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027. |
| Postal code | 90670-4634 |
| Report date | 20260708 |
| Product type | Drugs |
| Product quantity | 5,801 bottles |
| Reason for recall | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260408 |
| Initial firm notification | Press Release |
| Center classification date | 20260716 |
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 TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine...?
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 FirmBlaine Labs Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA
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🚨 SAFETY ALERT: Blaine Labs Inc - TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01 Check if your household is affected: https://therecallfile.com/recalls/terpenicol-antifungal-solution-undecylenic-10-undecenoic-acid-25-1-0-f/FDA-D-0697-2026
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