The Recall Desk
ModerateFDA (Drugs)·D-1024-2018·Announced 2018-08-08

West-Ward Recalls Doxycycline Hyclate Tablets for Dissolution Failures

West-Ward Columbus Inc is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible health consequences. The failure to meet dissolution specifications is a quality issue that may affect efficacy but is not associated with acute severe injury or death in this context.

Plain-English summary

West-Ward Columbus Inc is voluntarily recalling Doxycycline Hyclate Tablets, USP, 100 mg. The recall involves 29,048 bottles, containing a total of 1,452,400 tablets. The product is identified by Lot# 71545B and has an expiry date of 01/19. The NDC number is 0143-2112-50.

The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases properly in the body to provide the intended therapeutic effect. Failure to meet these specifications may result in the medication not working as intended.

The affected product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for the specific lot number and expiry date listed above. If the product is found, 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 lot.

The recalled product

Product
DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
Brand
DOXYCYCLINE HYCLATE
Manufacturer
West-Ward Columbus Inc
Category
Drug — Antibiotic
Hazard

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 (2)

  • Lot# 71545B
  • Expiry date: 01/19

UPCs (1)

  • 0301432112508

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by West-Ward Columbus 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 · DOXYCYCLINE HYCLATE

Same manufacturer · West-Ward Columbus Inc

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Same hazard · dissolution failure

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