busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
USbusPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Recalling Firm: Unichem Pharmaceuticals USA Inc.
Motif du rappel / Danger
TranslatedSubpotent drug
Description du produit & Identification
TranslatedbusPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Additional Source Details
| Field | Value |
|---|---|
| City | East Brunswick |
| State | NJ |
| Openfda › Upc › 1 | 0329300246018 |
| Openfda › Upc › 2 | 0329300245011 |
| Openfda › Upc › 3 | 0329300247015 |
| Openfda › Unii | 207LT9J9OC |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 866018 |
| Openfda › Rxcui › 2 | 866083 |
| Openfda › Rxcui › 3 | 866090 |
| Openfda › Rxcui › 4 | 866094 |
| Openfda › Spl id | ef78a61a-865b-447a-9324-3044e41db506 |
| Openfda › Brand name | BUSPIRONE HYDROCHLORIDE |
| Openfda › Spl set id | a6bdf140-075e-445e-a62d-633a4b97f3a8 |
| Openfda › Package ndc › 1 | 29300-244-01 |
| Openfda › Package ndc › 2 | 29300-244-05 |
| Openfda › Package ndc › 3 | 29300-245-01 |
| Openfda › Package ndc › 4 | 29300-245-05 |
| Openfda › Package ndc › 5 | 29300-246-01 |
| Openfda › Package ndc › 6 | 29300-246-18 |
| Openfda › Package ndc › 7 | 29300-246-05 |
| Openfda › Package ndc › 8 | 29300-246-16 |
| Openfda › Package ndc › 9 | 29300-247-16 |
| Openfda › Package ndc › 10 | 29300-247-01 |
| Openfda › Package ndc › 11 | 29300-247-05 |
| Openfda › Package ndc › 12 | 29300-477-16 |
| Openfda › Package ndc › 13 | 29300-477-01 |
| Openfda › Package ndc › 14 | 29300-477-18 |
| Openfda › Package ndc › 15 | 29300-477-05 |
| Openfda › Package ndc › 16 | 29300-478-16 |
| Openfda › Package ndc › 17 | 29300-478-01 |
| Openfda › Package ndc › 18 | 29300-478-05 |
| Openfda › Product ndc › 1 | 29300-244 |
| Openfda › Product ndc › 2 | 29300-245 |
| Openfda › Product ndc › 3 | 29300-246 |
| Openfda › Product ndc › 4 | 29300-247 |
| Openfda › Product ndc › 5 | 29300-477 |
| Openfda › Product ndc › 6 | 29300-478 |
| Openfda › Generic name | BUSPIRONE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | BUSPIRONE HYDROCHLORIDE |
| Openfda › Manufacturer name | Unichem Pharmaceuticals (USA), Inc. |
| Openfda › Application number | ANDA210907 |
| Openfda › Is original packager | true |
| Event id | 98728 |
| Address 1 | 1 Tower Center Blvd Ste 2200 |
| Code info | Lot: ZBUL25001, Exp 12/31/2027 |
| Postal code | 08816-1145 |
| Report date | 20260513 |
| Product type | Drugs |
| Product quantity | 10,875 Bottles |
| Reason for recall | Subpotent drug |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260413 |
| Initial firm notification | Letter |
| Center classification date | 20260501 |
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 busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind...?
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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Aperçu
- Entreprise responsableUnichem Pharmaceuticals USA Inc.
- StatusOngoing
- Niveau de risqueClass III
- DistributionUSA Nationwide
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🚨 SAFETY ALERT: Unichem Pharmaceuticals USA Inc. - busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05. Check if your household is affected: https://therecallfile.com/fr/recalls/buspirone-hydrochloride-tablets-usp-5-mg-500-count-bottle-rx-only-manu/FDA-D-0511-2026
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