Thrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida
Thrive Pharmacy is recalling 403 buprenorphine troches in Florida because they contain less active ingredient than labeled.
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 explicitly states the agency classification is Class II. According to the rubric, an FDA Class II recall must not be scored below 4 (Severe).
Plain-English summary
Thrive Pharmacy, located in Jacksonville, Florida, is voluntarily recalling 403 units of Buprenorphine Watermelon 8 mg Troches. The recall was initiated on March 10, 2020, and the product was distributed in Florida. The specific lot affected is 191203F, with an expiration date of 05/31/2020.
The reason for the recall is that the product is subpotent, meaning it contains less of the active drug ingredient than stated on the label. The FDA classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact Thrive Pharmacy for instructions on how to return or dispose of the medication. The recall status is currently terminated.
The recalled product
- Product
- Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
- Manufacturer
- Matthew 7:25 Inc dba Thrive Pharmacy
- Category
- Drug — Pharmaceutical
- Hazard
- Affected units
- 403
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)
- Lot: 191203F Exp. 05/31/2020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Matthew 7:25 Inc dba Thrive Pharmacy 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Matthew 7:25 Inc dba Thrive Pharmacy
See all →- SevereThrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida
FDA (Drugs) · 2020-04-01
- SevereThrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida
FDA (Drugs) · 2020-04-01
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