Wecare Calasoothe recalled over current good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 2400 containers of Wecare Calasoothe over current good manufacturing practice deviations.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
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 →- SevereBaxter Recalls Vasopressin 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 Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateWeCare zinc oxide ointment recalled over good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateDynashield cream recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateWound hydrogel recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateClotrimazole cream, 1 ounce size, recalled over good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateClotrimazole cream, 5 ounce size, recalled over good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateLanashield Skin Barrier recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-10