Wecare Enema recalled over current good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 18,912 containers of Wecare Enema, 4.5 Fl Oz, 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 Enema, 4.5 Fl Oz (133mL), made in India and manufactured for Dynarex Corporation of Middletown, New York, under NDC 67777-402-01, is being recalled.
The reason given in the enforcement record is cGMP deviations.
The recall covers 18,912 containers from lots A022310, expiry 2/26; A022335, expiry 10/26; A022406, expiry 12/27; and A022505, expiry 12/27. 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
- Women s Hormone Test
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Category
- Drug — Enema
- Affected units
- 37
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: 616612786999
- SKU: O935
- 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.
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