Nostrum Recalls Calcium Acetate Capsules Due to Foreign Material Presence
Nostrum Laboratories is recalling Calcium Acetate Capsules because foreign tablets or capsules were found in the product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Nostrum Laboratories, Inc. is recalling Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. The product is identified by NDC 29033-026-02, Lot CAL173502, and an expiration date of 09/19. The recall involves 1,439,000 oral capsules.
The recall was initiated due to the presence of foreign tablets or capsules in the product. The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02
- Manufacturer
- Nostrum Laboratories Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,439,000
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: CAL173502
- Exp. 09/19
Distribution
Distributed nationwide across the United States.
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