Fresenius Recalls phosLo Calcium Acetate GelCaps Due to Cross-Contamination
Fresenius Medical Care is recalling specific lots of phosLo (calcium acetate) GelCaps due to cross-contamination with a tricyclic antidepressant found on the packaging.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant contamination risks, even if specific injury reports are not detailed in the provided text.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 14,496 bottles of phosLo (calcium acetate) GelCaps, 667 mg, 200-count. The affected products are prescription-only and were distributed in Pennsylvania. The recall involves Lot # 13064, 13065, and 13066, which have an expiration date of 08/18.
The recall was initiated due to cross-contamination with other products. Chemical analysis identified the contaminant on the cotton packaging inside the bottles as a formulation of 4% Trimipramine methanesulfonate, which is a tricyclic antidepressant.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or supplier for a refund or replacement.
The recalled product
- Product
- phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Drug — Pharmaceuticals
- Affected units
- 14,496
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 (4)
- Lot # 13064
- 13065
- 13066
- Exp. 08/18
Distribution
Distributed in 1 state:
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