Emergency Product Recall Procedure

1. Purpose

This procedure establishes a written process for identifying, deciding, executing, documenting, and closing emergency recalls of Caliber Labs research reference standards that may pose a quality, safety, or compliance risk to qualified research buyers.

2. Scope

This procedure applies to all peptide and related research reference materials distributed by Caliber Labs, including finished lots in inventory, lots in transit, and lots already delivered to customers when a recall condition is identified.

This procedure works in conjunction with the Quality Assurance Plan.

3. Definitions

• Recall: removal or correction of distributed product because it violates Caliber Labs quality standards or may be unfit for its intended research reference use.
• Lot / batch: a defined quantity of material manufactured or received under uniform conditions and identified by a single lot number.
• Quarantine: controlled hold status preventing further distribution of suspect material.
• Market withdrawal: return of product not yet shipped or still in Caliber Labs control; handled under the same decision framework as a recall.

4. Recall classification

Recalls are classified by severity:

• Class I: reasonable probability that use of the lot could cause serious adverse consequences to research integrity, laboratory safety, or compliance; immediate action required.
• Class II: material may cause temporary or reversible research impact, misidentification, or measurable quality deviation; prompt action required.
• Class III: unlikely to cause significant research impact but fails documented specifications or labeling; correction initiated without undue delay.

5. Recall team and responsibilities

When a potential recall is identified, Caliber Labs management designates a Recall Coordinator and assembles a recall team as needed.

• Recall Coordinator: leads investigation, documents decisions, and directs notifications
• Quality Responsible Person: confirms analytical findings and approves recall initiation and closure
• Operations: quarantines inventory, halts fulfillment, and coordinates physical retrieval
• Customer Communications: notifies affected buyers and records responses

Primary recall contact: support@caliberlabs.co · (786) 508-2985

6. Triggers for recall evaluation

A recall evaluation is initiated when any of the following occur:

• Failed or invalidated third-party analytical results for a released lot
• Confirmed mislabeling, mix-up, or incorrect product identity
• Confirmed contamination, degradation, or out-of-specification purity
• AuthentiChain certification revocation or material COA discrepancy
• Supplier notification of manufacturing deviation affecting received lots
• Repeated customer complaints indicating a systemic lot defect
• Storage or shipping condition failure affecting product integrity
• Regulatory, legal, or institutional notice requiring product retrieval

7. Recall decision and initiation

1. Document the event, affected lot numbers, and date of discovery.
2. Immediately quarantine all affected inventory in Caliber Labs control.
3. Stop shipment of suspect lots and flag related open orders.
4. Identify all customers who received the affected lot(s) using order and lot records.
5. The Quality Responsible Person approves or rejects formal recall initiation within one (1) business day of confirmed trigger evidence.
6. Upon approval, the Recall Coordinator activates this procedure and assigns recall classification (Class I, II, or III).

8. Customer notification

Affected customers are notified without undue delay using the contact information on file. Notifications include:

• Product name and catalog identifier
• Lot / batch number
• Reason for recall
• Recall classification
• Instructions to discontinue use, segregate material, and await return authorization
• Recall Coordinator contact information

For Class I recalls, initial notification is targeted within twenty-four (24) hours of recall approval. Class II and III recalls are initiated within seventy-two (72) hours unless immediate risk requires faster action.

9. Product retrieval and disposition

Returned or retrieved product is quarantined in a designated area separate from approved inventory. Customers receive written return instructions, including shipping authorization, when applicable.

Disposition options include:

• Replacement with a conforming lot, when available
• Credit or refund in accordance with the Refund Policy
• Destruction of non-conforming material under documented control

Opened research materials may not be resold. Disposition decisions are documented in the recall file.

10. Public and partner notification

Where AuthentiChain or other verification partners have published certification for an affected lot, Caliber Labs will request correction or removal of public COA records as appropriate.

If required by law, institutional agreement, or severity of the event, management may issue broader notice through the website, email, or direct institutional contact.

11. Investigation, CAPA, and effectiveness check

Each recall includes a documented root-cause investigation and corrective and preventive action (CAPA) plan. Effectiveness is verified by reviewing whether:

• 100% of known affected customers were contacted or accounted for
• All quarantined and returned inventory was dispositioned
• The root cause was addressed and recurrence controls were implemented

The recall file is closed only after the Quality Responsible Person approves the effectiveness review.

12. Records

Recall records are maintained for a minimum of three (3) years and include the trigger report, lot traceability, customer notification log, retrieval documentation, investigation, CAPA, and closure approval.

13. Plan review

This Emergency Product Recall Procedure is reviewed at least annually and after any actual recall event. Updates are approved by Caliber Labs management.