Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported January 9, 2019
Vitamin B12 liquid 1000mcg/ml, RX, glass vial
Lack of sterility assurance.
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalled Vitamin B12 liquid 1000mcg/ml, RX, glass vial - a moderate-severity action.
Vitamin B12 liquid 1000mcg/ml, RX, glass vial was recalled by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy in January 9, 2019. Reason: Lack of sterility assurance.. Check the official notice for the remedy. Verify recall #D-0402-2019 with the FDA Drug before acting.
The recall
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy issued this moderate-severity FDA Drug recall-Lack of sterility assurance..
- Moderate
- severity level
- Class II
- classification
- January 9, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0402-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0402-2019) was formally reported on January 9, 2019, with the manufacturer initiating the action on January 2, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is listed as the recalling firm, operating out of Roseburg, OR. Federal records list the affected scope as 150 ml.
The documented reason for this recall is: Lack of sterility assurance. Distribution data in the federal record shows the product reached: Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each pat…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Dietary Supplements recalls over time
Where this recall sits in its category - 2,002 dietary supplements recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
150 ml
Related Recalls
6
0 from same agency
Product description
Vitamin B12 liquid 1000mcg/ml, RX, glass vial
Reason for recall
Lack of sterility assurance.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0402-2019 |
| Date reported | January 9, 2019 |
| Date initiated | January 2, 2019 |
| Recalling firm | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy |
| Firm location | Roseburg, OR |
| Affected scope | 150 ml |
| Distribution | Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not … |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0402-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Vitamin B12 liquid 1000mcg/ml, RX, glass vial. Recalled by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy. Units affected: 150 ml.
Why was this product recalled? ▼
Lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 9, 2019. Severity: Moderate. Recall number: D-0402-2019.
Where was the recalled product distributed? ▼
Distribution: Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0402-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Food Critical
Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Ent…
Pure Vitamins and Natural Supplements, LLC · 2026-04-15
FDA Food Critical
Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Enti…
Pure Vitamins and Natural Supplements, LLC · 2026-04-15
FDA Food Moderate
Bulk packaged Colustrum Powder. packaged with generic product label.
Herbal Creations USA · 2026-04-01
FDA Food Low
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; N…
Winder Laboratories, LLC · 2026-03-25
FDA Food Moderate
Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for t…
Imu-Tek Animal Health, Incorporated · 2026-02-11
Compare this recall with Blue Bull Extreme Male Enhancement Supplement, total of 15 … →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 9, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.