Boehringer Ingelheim Roxane Recalls Prednisone Tablets Due to Missing Label
Boehringer Ingelheim Roxane Inc is recalling 14,619 cartons of Prednisone 20 mg tablets because the blister cards are missing labels.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific hazard is a missing label, which is a documentation/packaging issue.
Plain-English summary
Boehringer Ingelheim Roxane Inc is recalling 14,619 cartons of Prednisone Tablet USP, 20 mg tablets. The affected product is identified by lot #261739A and has an expiration date of OCT 2014. The product is packaged in blisters of ten tablets per blister card, with ten blister cards per carton, and carries the NDC 0054-0018-20.
The recall was initiated due to a labeling defect where the blister cards are missing labels. This issue affects the product's identification and safety verification. The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for Prednisone 20 mg tablets with lot #261739A and expiration date OCT 2014. If found, the product should be returned to the pharmacy or point of purchase for replacement or refund.
The recalled product
- Product
- PREDNISONE (PREDNISONE)
- Brand
- PREDNISONE
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 14,619
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)
- The affected product consists of lot #261739A
- expiration date OCT 2014.
UPCs (1)
- 0300543722507
Distribution
Distributed nationwide across the United States.
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