Tetracycline Hydrochloride Capsule
FDA Recall NDC 23155-017
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Tetracycline Hydrochloride (NDC 23155-017). A significant event, classified as Class I, was initiated on Mar 23, 2020 by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Mar 23, 2020
Apr 15, 2020
4,444 bottles
Recall Profile & Regulatory Data
Event ID
85307
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Avet Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Aug 23, 2022
Product Description
Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01
Batch or Lot Expiration Information
Lot# H190666, Exp JUL 2022
Affected Packages Involved in this Recall
23155-017-01Product
23155-018-01Product
Class I Terminated
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Mar 23, 2020
Apr 15, 2020
17,524 bottles
Recall Profile & Regulatory Data
Event ID
85307
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Avet Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Aug 23, 2022
Product Description
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01
Batch or Lot Expiration Information
Lot# s: G190609, G190610, G190611, Exp Jun 2022: L191027, L191028, Exp Nov 2022: K190953, K190952, Exp Oct 2022
Affected Packages Involved in this Recall
23155-017-01Product
23155-018-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
