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Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01

Drug Recall

Official source record

Recall number
D-1255-2020
Event ID
85307
Classification
Class I
Status
Terminated
Recalling company
Avet Pharmaceuticals, Inc.
Reason for recall
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Report date
April 15, 2020
Recall initiation date
March 23, 2020
Termination date
August 23, 2022
Distribution pattern
Distributed Nationwide in the US

Drug product identifiers

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Brand name
TETRACYCLINE HYDROCHLORIDE
Generic name
TETRACYCLINE HYDROCHLORIDE
Substance name
TETRACYCLINE HYDROCHLORIDE
Product NDCs
23155-017; 23155-018
Package NDCs
23155-017-01; 23155-018-01
Route
ORAL

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class I mean?

A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.

Is this recall still active?

According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this medication?

Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.

Where can I find more official information?

The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.