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D-0889-2018 Class II Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

FDA drug recall D-0889-2018 was initiated by Advanced Pharma Inc. on Jun 20, 2018 and is designated Class II. Reason for recall: Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label. The recall status is terminated (terminated Apr 3, 2019). Affected quantity: 100 syringes.

Recall Details

Product Type: Drugs
Report Date: Jul 4, 2018
Initiation Date: Jun 20, 2018
Termination Date: Apr 3, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 100 syringes

Product Description

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.

Distribution Pattern

Distributed to one medical center in Fort Worth, TX.

Code Information

Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0889-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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