Par Pharmaceutical Recalls Prednisone Tablets Due to Incorrect Expiration Date
Par Pharmaceutical Inc. is recalling 13,008 bottles of Prednisone Tablets USP 5 mg because an incorrect expiration date was identified on the product.
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 hazard is a documentation/labeling issue.
Plain-English summary
Par Pharmaceutical Inc. is recalling 13,008 bottles of Prednisone Tablets USP 5 mg, 48-count, Rx only. The recall was initiated because an incorrect expiration date was identified on the product. The affected product is distributed nationwide in the U.S.A. and is identified by Lot # 8672518 with an expiration date of 12/21.
The FDA has classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences. The issue is strictly related to labeling accuracy regarding the expiration date.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- PREDNISONE (PREDNISONE)
- Brand
- PREDNISONE
- Manufacturer
- Par Pharmaceutical Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 13,008
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 #: 8672518
- Exp 12/21
UPCs (7)
- 0306035338317
- 0306035337211
- 0306035338157
- 0306035335217
- 0306035336214
- 0306035337310
- 0306035338218
Distribution
Distributed nationwide across the United States.
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