Boehringer Ingelheim Roxane Recalls Calcitriol Oral Solution Due to Impurity
Boehringer Ingelheim Roxane Inc. is recalling 5,364 bottles of Calcitriol Oral Solution 1 mcg/mL due to a failed impurity specification.
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 FDA classified this recall as Class II. Per the rubric, an FDA Class II recall with potential for adverse health consequences (implied by the impurity failure) maps to a severity score of 4 (Severe), as it is not Class I (Critical) but involves a significant quality failure.
Plain-English summary
Boehringer Ingelheim Roxane Inc. is recalling 5,364 bottles of Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only. The product is identified by NDC 0054-3120-41, Lot # 360122A, and an expiration date of MAY 2015. The recall was initiated because the product failed an impurity/degradation specification, specifically being out of specification for trans-calcitriol degradant at the 9-month stability time point.
The affected product was distributed nationwide. This is a prescription-only medication manufactured by Boehringer Ingelheim Roxane Inc. (Roxane Laboratories, Inc., Columbus, Ohio). The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The recall is limited to the specific lot and expiration date listed above.
The recalled product
- Product
- CALCITRIOL (CALCITRIOL)
- Brand
- CALCITRIOL
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 5,364
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 # 360122A
- EXP Date: MAY 2015
Distribution
Distributed nationwide across the United States.
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