FDA Recall Database: Class II Recall: Total Parental Nutrition - Pediatric PN Patient-Specific TPN… by Central Admixture Pharmacy Services, Inc.

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Central Admixture Pharmacy Services, Inc. and the affected product is described in FDA's record as: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts (additional items listed in FDA's full record). FDA's stated reason for the recall is: Incorrect product formulation: bag did not contain copper and famotidine per label.. The recall is tracked under FDA recall number D-0618-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts (additional items listed in FDA's full record) -- and the recall number D-0618-2026. If it matches, stop using or distributing it and contact Central Admixture Pharmacy Services, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Central Admixture Pharmacy Services, Inc.’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Central Admixture Pharmacy Services, Inc.: 0 warning letters, 1 recall, 0 approval records, and 2 Form 483 inspection citations.

Frequently asked questions

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Central Admixture Pharmacy Services, Inc. recalled Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts (additional items listed in FDA's full record). FDA's record states the reason for recall as: Incorrect product formulation: bag did not contain copper and famotidine per label.. The recall is logged under FDA recall number D-0618-2026 with a Class II classification.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

Related enforcement actions