fentanyl Citrate USP 5 mcg in 0 — Class II drug recall D-0889-2018
Terminated recall by Advanced Pharma Inc., reported 2018-07-04, distributed in TX. Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
| Recall number | D-0889-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Pharma Inc., Houston, TX, United States |
| Recall initiated | 2018-06-20 |
| Classified | 2018-06-25 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2019-04-03 |
| Distributed | TX |
| Quantity | 100 syringes |
| Reason classes | labeling, potency |
| NDC | 15082-0210-72 |
| Lot numbers | 0432, 149-21072S |
| Expiration dates | 2018-09-10 |
Product
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
Reason for recall
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
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-0889-2018. 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.