Downing Labs Recalls EDTA Calcium Disodium Injectable Due to Sterility Concerns
Downing Labs is recalling 104 vials of EDTA Calcium Disodium Injectable because the company cannot assure the product's sterility.
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. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in an injectable) corresponds to a Severe rating.
Plain-English summary
Downing Labs, LLC is recalling 104 vials of EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial. The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product is a prescription-only injectable. The recall covers all lots of the product. The product was distributed nationwide in the US as well as in Australia, Brazil, the Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, the Philippines, Singapore, Thailand, Trinidad and Tobago, and Taiwan.
Consumers and healthcare providers should stop using the recalled product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions.
The recalled product
- Product
- EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
- Manufacturer
- Downing Labs, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 104
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 48 recalled by Downing Labs, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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