Multi-event March 2020 FDA Recall Tetracycline Hydrochloride by Avet Pharmaceuticals, Inc.
This Multi-event Class I drug recall was voluntarily initiated by Avet Pharmaceuticals, Inc. on March 23, 2020 for the product Tetracycline Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1255-2020
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
03-23-2020
04-15-2020
4,444 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Avet Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the US
08-23-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1254-2020
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
03-23-2020
04-15-2020
17,524 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Avet Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the US
08-23-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
