Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures
Teva Pharmaceuticals is recalling Paricalcitol Capsules because stability testing revealed out-of-specification impurities. The recall covers 30,891 bottles distributed nationwide and in Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential health risks such as impurities, even if specific injury reports are not detailed in the provided text.
Plain-English summary
Teva Pharmaceuticals USA is recalling Paricalcitol Capsules, 1 mcg, 30 tablets per bottle (NDC 0093-7656-56). The recall was initiated because stability testing produced out-of-specification results for impurities. The affected product is Lot # 13013.009A with an expiration date of 02/2016.
A total of 30,891 bottles were distributed nationwide and in Puerto Rico. The product was manufactured by Pharmaceutics International, Inc., and manufactured for Teva Pharmaceuticals USA. This is a prescription-only medication.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternatives or returns.
The recalled product
- Product
- Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 30,891
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 #: 13013.009A
- Exp. 02/2016
Distribution
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