Abbott Recalls Zemplar Injection Due to Potential Foreign Stopper Contamination
Abbott Laboratories is recalling Zemplar (paricalcitol) Injection due to a potential CGMP deviation where a foreign stopper may have been applied to vials.
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 under the rubric, particularly given the risk of foreign object contamination in an injectable medication.
Plain-English summary
Abbott Laboratories is recalling Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials. The recall involves 121,000 vials from Lot # 11-122-DK, which expires in October 2013. The product is distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. There is a potential that Abbott's third-party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in this specific lot. This is classified as an FDA Class II recall.
Healthcare providers and patients should discontinue use of the affected lot and contact Abbott Laboratories for further instructions or replacement.
The recalled product
- Product
- ZEMPLAR (PARICALCITOL)
- Brand
- ZEMPLAR
- Manufacturer
- Abbott Laboratories
- Category
- Drug — Injectable
- Affected units
- 121,000
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 #: 11-122-DK
- Exp 10/13
Distribution
Distributed nationwide across the United States.
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