The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1254-2020·Announced 2020-04-15

Avet Pharmaceuticals Recalls Tetracycline Hydrochloride Capsules for Dissolution Failures

Avet Pharmaceuticals is recalling 17,524 bottles of Tetracycline Hydrochloride 500 mg capsules because they failed dissolution specifications during long-term testing.

The agency’s classification

FDA (Drugs): Class I

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.

Plain-English summary

Avet Pharmaceuticals, Inc. is recalling 17,524 bottles of Tetracycline Hydrochloride Capsules, USP, 500 mg, 100-count. The product is a prescription-only medication manufactured for Heritage Pharmaceuticals Inc. and distributed nationwide in the US. The recall is due to out-of-specification results during long-term testing for dissolution.

The affected lots are G190609, G190610, and G190611 (Expiration: Jun 2022), L191027 and L191028 (Expiration: Nov 2022), and K190953 and K190952 (Expiration: Oct 2022). The NDC codes for the recalled product are 23155-018-01 and 23155-017-01.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this specific medication.

The recalled product

Product
TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE HYDROCHLORIDE)
Brand
TETRACYCLINE HYDROCHLORIDE
Manufacturer
Avet Pharmaceuticals, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
17,524

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot #s: G190609
  • G190610
  • G190611
  • Exp Jun 2022: L191027
  • L191028
  • Exp Nov 2022: K190953
  • K190952
  • Exp Oct 2022

UPCs (1)

  • 0323155017014

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Avet Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · TETRACYCLINE HYDROCHLORIDE

Same manufacturer · Avet Pharmaceuticals, Inc.

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Same hazard · dissolution failure

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