Z-2785-2016Class II
GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
Allergy Laboratories, Inc. / initiated 2015-02-03 / Terminated / root cause: manufacturing process
Allergy Laboratories, Inc. began a recall of GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap on . FDA classified it as Class II and gives the reason as "Potential for glass particles within the vials". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2785-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Allergy Laboratories, Inc.
- Product
- GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
- Product code
- LDH
- Reason for recall
- Potential for glass particles within the vials
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Allergy Laboratories notified the sole consignee via phone call on February 3, 2015. For further information, please call (405) 235-1451.
- Quantity in commerce
- 81,625 vials (3,265 packs)
- Distribution
- US Distribution to the state of : NC
- Product codes and lots
- SEV2120414, SEV2120514
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2785-2016 | Class II | Terminated | Voluntary: Firm initiated |
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