Promise Pharmacy Recalls Thymosin Beta-4 Injections Due to Sterility Concerns
Promise Pharmacy is recalling 94 vials of Thymosin Beta-4, 15 mg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.
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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk conditions.
Plain-English summary
Promise Pharmacy, LLC is recalling 94 vials of Thymosin Beta-4, 15 mg Injection, Rx Only. The recall is being conducted due to a lack of sterility assurance. The affected product was distributed nationwide in the USA.
The specific lots involved are 08302018@8 with a best use date of 2/26/2019, 10012018@2 with a best use date of 3/30/2019, and 07052018@2 with a best use date of 01/01/2019. The product is manufactured by Promise Pharmacy, LLC, located at 31818 US Hwy 19N, Palm Harbor, FL 34684.
Consumers and healthcare providers should check their inventory for these specific lot numbers and best use dates. If the product is found, it should be returned to the pharmacy or disposed of according to local regulations. Patients who have already received the injection should contact their healthcare provider for guidance.
The recalled product
- Product
- Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Hazard
- Affected units
- 94
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 (3)
- Lots: 08302018@8 BUD: 2/26/2019
- 10012018@2 BUD: 3/30/2019
- 07052018@2 BUD: 01/01/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, 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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