Promise Pharmacy Recalls Glutathione Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling specific lots of Glutathione Injection because of a lack of sterility assurance. The affected products were distributed nationwide.
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 source text identifies the hazard as a lack of sterility assurance in an injectable drug, which carries a significant risk of serious injury or infection. Per the rubric, structural defects or significant injury risks in medical products align with a Severe (4) classification.
Plain-English summary
Promise Pharmacy, LLC is recalling 288 10 mL vials of Glutathione Injection, 200 mg/mL, Rx Only. The recall is due to a lack of sterility assurance. The affected products include lots 09172018@7 with a best-use date of 12/16/2018, and 10292018@2 with a best-use date of 1/27/2019.
The recalled products were distributed nationwide in the USA. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Injectable
- Hazard
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)
- Lots: 09172018@7 BUD: 12/16/2018
- 10292018@2 BUD: 1/27/2019
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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