Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
USAlendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
Recalling Firm: Hikma Pharmaceuticals USA INC
Motif du rappel / Danger
TranslatedThis recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Description du produit & Identification
TranslatedAlendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
Additional Source Details
| Field | Value |
|---|---|
| City | Columbus |
| State | OH |
| Openfda › Upc | 0300540282592 |
| Openfda › Unii | 2UY4M2U3RA |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 904447 |
| Openfda › Spl id | 56e063a8-8c3d-4445-91fd-0c8806c2b127 |
| Openfda › Brand name | ALENDRONATE SODIUM |
| Openfda › Spl set id | c910bb05-279b-4ffa-a867-46f4a0853ed5 |
| Openfda › Package ndc | 0054-0282-59 |
| Openfda › Product ndc | 0054-0282 |
| Openfda › Generic name | ALENDRONATE SODIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | ALENDRONATE SODIUM |
| Openfda › Manufacturer name | Hikma Pharmaceuticals USA Inc. |
| Openfda › Application number | ANDA090520 |
| Openfda › Is original packager | true |
| Event id | 98744 |
| Address 1 | 1809 Wilson Rd |
| Code info | Lot # AC2040A, Exp Date: 04/2026 |
| Postal code | 43228-9579 |
| Report date | 20260506 |
| Product type | Drugs |
| Product quantity | 4 single dose 75 ml bottles |
| Reason for recall | This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260407 |
| Initial firm notification | Letter |
| Center classification date | 20260508 |
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 Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharma...?
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 responsableHikma Pharmaceuticals USA INC
- StatusOngoing
- Niveau de risqueClass II
- DistributionUS Nationwide.
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🚨 SAFETY ALERT: Hikma Pharmaceuticals USA INC - Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59. Check if your household is affected: https://therecallfile.com/fr/recalls/alendronate-sodium-oral-solution-70-mg-75-ml-75-ml-rx-only-4-x-75-ml-s/FDA-D-0526-2026
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