FDA Recall United States Terminated Historical recordClass III
Pure Encapsulations, Inc.
- Product
- Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEME…
- Published
- December 6, 2017
- Distribution
- Multiple states
Pure Encapsulations, Inc. Recall: Product contains undeclared sulfites.
United States
TerminatedClass III
- Company
- Pure Encapsulations, Inc.
- Product
- pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSUL…
- Recall date
- November 17, 2017
- Terminated
- December 27, 2017
- Source
- FDA
Reason for recall
Product contains undeclared sulfites.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 60 CAPSULES UPC: 7 66298 00317 7 | Not published in this source record | N/A | All lots within expiry. AI Enzymes 120: 50048025 50058242 50063516 50067188 50076912 50080121 50092381 50092382 50104459 50108093 50114435 50118464 50125714 AI Enzymes 60: 50048027 50058243 50063517 50067189 50080122 50097606 50104460 50108094 50114436 50118465 |
Distribution
- NH
- AZ
- CO
- OH
- NC
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-0397-2018
- Event ID
- 78589
- Status
- Terminated
- Classification
- Class III
- Company
- Pure Encapsulations, Inc.
- Product description
- pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 60 CAPSULES UPC: 7 66298 00317 7
- Quantity
- N/A
- Reason
- Product contains undeclared sulfites.
- Recall initiation date
- November 17, 2017
- Report date
- December 6, 2017
- Classification date
- Not published in this source record
- Termination date
- December 27, 2017
- Distribution pattern
- NH, AZ, CO, OH, NC
- UPC, lot, and code information
- All lots within expiry. AI Enzymes 120: 50048025 50058242 50063516 50067188 50076912 50080121 50092381 50092382 50104459 50108093 50114435 50118464 50125714 AI Enzymes 60: 50048027 50058243 50063517 50067189 50080122 50097606 50104460 50108094 50114436 50118465
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Other products recalled under this same event
This recall shares FDA event ID 78589 with 1 other product entry in Public Health Trace.
Responsible company: Pure Encapsulations, Inc.
Other recalls from Pure Encapsulations, Inc.
FDA Recall United States Terminated Historical recordClass III
Pure Encapsulations, Inc.
- Product
- Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEME…
- Published
- December 6, 2017
- Distribution
- Multiple states
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| New Hampshire | 1 |
| Arizona | 1 |
| Colorado | 1 |
| Ohio | 1 |
| North Carolina | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
