The Recall Desk
SevereFDA (Drugs)·D-796-2014·Announced 2014-01-29

Buprenorphine HCL Tablets Recalled for Potential Label Mixup

Aidapak Services, LLC is recalling Buprenorphine HCL SL tablets due to a potential label mixup with other medications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric, as it involves a labeling error that could lead to serious adverse health consequences.

Plain-English summary

Aidapak Services, LLC is recalling Buprenorphine HCL SL, Tablet, 2 mg (NDC 00054017613) because the product may be potentially mislabeled as Docusate Sodium, Capsule, 250 mg or Magnesium Chloride DR, Tablet, 64 mg. The recall is classified as FDA Class II.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific lots involved include Pedigree AD39573_1 with an expiration date of 5/13/2014 and Pedigree AD54478_1 with an expiration date of 5/20/2014.

Consumers should check their medication labels and consult their healthcare provider or pharmacist if they have questions regarding this recall.

The recalled product

Product
BUPRENORPHINE HCL SL, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054017613.
Affected units
60

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 (6)

  • BUPRENORPHINE HCL SL
  • Tablet
  • 2 mg has the following codes: Pedigree: AD39573_1
  • EXP: 5/13/2014
  • Pedigree: AD54478_1
  • EXP: 5/20/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 recalled by Aidapak Services, LLC 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 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →