CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
USCLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
Recalling Firm: Heritage Pharmaceuticals Inc
Reason for Recall / Hazard
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Product Description & Identification
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
Additional Source Details
| Field | Value |
|---|---|
| City | East Brunswick |
| State | NJ |
| Openfda › Unii | VN9A8JM7M7 |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 562266 |
| Openfda › Spl id | 6b2e0bbb-397e-49b2-aaea-3ec3896b8beb |
| Openfda › Brand name | CLINDAMYCIN PALMITATE HYDROCHLORIDE |
| Openfda › Spl set id | a2279019-9341-4346-8746-fea262b27dd8 |
| Openfda › Package ndc | 23155-603-51 |
| Openfda › Product ndc | 23155-603 |
| Openfda › Generic name | CLINDAMYCIN PALMITATE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | CLINDAMYCIN PALMITATE HYDROCHLORIDE |
| Openfda › Manufacturer name | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
| Openfda › Application number | ANDA207047 |
| Openfda › Is original packager | true |
| Event id | 99526 |
| Address 1 | 1 Tower Center Blvd Ste 1700 |
| Code info | Lot #: 2411550, Exp. 2026/NOV. |
| Postal code | 08816-1145 |
| Report date | 20260819 |
| Product type | Drugs |
| Reason for recall | Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260730 |
| Initial firm notification | Letter |
| Center classification date | 20260814 |
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Overview
- Recalling FirmHeritage Pharmaceuticals Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the U.S
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🚨 SAFETY ALERT: Heritage Pharmaceuticals Inc - CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51 Check if your household is affected: https://therecallfile.com/recalls/clindamycin-palmitate-hydrochloride-for-oral-solution-usp-75-mg-5-ml-r/FDA-D-0768-2026
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