CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceut
Summary
The FDA issued a Class II for CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, by Heritage Pharmaceuticals Inc. Reason: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles..
Details
Source
Drug Recall
External ID
D-0768-2026
Action Date
2026-08-19
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 2411550, Exp. 2026/NOV.
Reason for Recall
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Distribution
Nationwide within the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-30
Company
East Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 28 drug recalls issued in the same week, part of 68 drug-related FDA actions this month.
Heritage Pharmaceuticals Inc has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Heritage Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Heritage Pharmaceuticals Inc have FDA actions?
Heritage Pharmaceuticals Inc has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0768-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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