The Recall Desk
LowFDA (Drugs)·D-578-2013·Announced 2013-06-12

Teva Recalls Disulfiram Tablets Due to Missing Cotton Coil

Teva Pharmaceuticals is recalling 68,322 bottles of Disulfiram Tablets USP 250 mg because some packaged bottles are missing a cotton coil.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a violation of labeling or CGMP that is not likely to cause adverse health consequences. The missing cotton coil is a packaging defect with no reported injuries or illnesses.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 68,322 bottles of Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only. The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation where a cotton coil is missing in some of the packaged bottles.

The affected product is identified by NDC 0093-5035-01. Specific lot numbers and expiration dates are listed in the recall details, including lots expiring in 2014 and 2015. The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement in accordance with the recalling firm's instructions.

The recalled product

Product
Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01
Affected units
68,322

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 (20)

  • NDC 0093-5035-01
  • Lot numbers 14064211A
  • exp 3/2014
  • 14064311A
  • 14064411A
  • 14064511A
  • 14090312A
  • exp 4/2015
  • 14092512A
  • 14092712A
  • 14094612A
  • 14099412A
  • 14099612B
  • 14099712A
  • exp 5/2015
  • 14110111A
  • exp 5/2014
  • 14110211A
  • 14110311A
  • 14110411A

Distribution

Distributed nationwide across the United States.