Wecare Calasoothe recalled over current good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 2400 containers of Wecare Calasoothe over current good manufacturing practice deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites current good manufacturing practice deviations with no stated product defect or reported harm.
Plain-English summary
Wecare Calasoothe, net weight 4 oz (113 g), NDC 67777-234-04, manufactured for Dynarex Corporation of Orangeburg, New York, is being recalled.
The reason given in the enforcement record is cGMP deviations.
The recall covers 2400 containers from lot A482305. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without describing a specific product defect, and states no injuries. Customers should follow the firm's instructions.
The recalled product
- Product
- Diabetes HbA1c Test
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Category
- Drug — Skin protectant
- Affected units
- 148
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 (4)
- EAN: 7340221707191
- SKU: A-HbA1c
- UDI-DI: None
- Lot/Serial Number: All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 92 recalled by GET TESTED INTERNATIONAL AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 92 products in this recall →Related recalls
Same manufacturer · GET TESTED INTERNATIONAL AB
See all →- ModerateGut Microbiome Test Large recalled for distribution without premarket clearance
FDA (Devices) · 2025-12-10
- ModerateThyroid TSH tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateOvulation test kits recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateSerotonin tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateChlamydia tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
Same hazard · cgmp deviation
See all →- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Vancomycin Injection Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09