Sermorelin 6mg/6mL Lyophilized Powder — Class II drug recall D-0006-2016
Terminated recall by Diabetes Corporation of America dba DCA Pharmacy, reported 2015-10-14, distributed in KY, OH, TN. Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an
| Recall number | D-0006-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN, United States |
| Recall initiated | 2015-09-23 |
| Classified | 2015-10-05 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-01-12 |
| Distributed | KY, OH, TN |
| Quantity | 129 vials |
| Reason classes | sterility |
| Lot numbers | 101614 |
| Expiration dates | 2015-04-30 |
Product
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
Reason for recall
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0006-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.