The Recall Desk
ModerateFDA (Drugs)·D-0816-2018·Announced 2018-05-23

L. Perrigo Recalls Scopolamine Transdermal System Due to Defective Delivery System

L. Perrigo is recalling 569,520 cartons of Scopolamine Transdermal System nationwide due to a defective delivery system.

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 corresponds to a moderate severity level where the product may cause temporary or medically reversible adverse health consequences, but no serious injury or death is reported.

Plain-English summary

L. Perrigo Company is recalling 569,520 cartons of Scopolamine Transdermal System, 1 mg/3 days, in 4-count, 10-count, and 24-count packages. The product is distributed nationwide in the U.S.A. and is manufactured by Aveva Drug Delivery Systems, a Nitto Denko Company, and distributed by Perrigo.

The recall is being conducted due to a defective delivery system. The affected lots include specific expiration dates ranging from March 2019 to October 2019, as detailed in the recall notice.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
SCOPOLAMINE TRANSDERMAL SYSTEM (SCOPOLAMINE TRANSDERMAL SYSTEM)
Brand
SCOPOLAMINE TRANSDERMAL SYSTEM
Manufacturer
L. Perrigo Company
Affected units
569,520

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)

  • Lot #: a) 46397
  • 46457 Exp 03/19
  • 46621
  • Exp 04/19
  • 46894
  • 46904
  • 46905
  • Exp 06/19
  • 47133
  • Exp 07/19
  • 47153
  • Exp 08/19
  • 47154
  • 47213
  • 47214
  • Exp 09/19
  • b) 46695
  • 46994
  • 47012
  • 47322 10/19

Distribution

Distributed nationwide across the United States.