When a shipment goes out of range, act in this order.
Storage and transport failures can become FDA recalls. On 7 October 2026 FDA posted a Zoladex recall after the product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours. In February 2026, 116 serialized cartons of Udenyca were recalled, Class I, after being stored at controlled room temperature instead of refrigerated at a distributor.
For: Quality and warehouse teams at drug manufacturers, wholesalers, 3PLs, pharmacies and food shippers and receivers. Sources: openFDA, recall D-0875-2026; openFDA, recall D-0353-2026.
What to do
Law a legal requirement, with its source. Good practice recommended by the regulator or industry, not required.
Detect and hold
- Law Write the required temperature into the shipping instructions. Food shippers must give the carrier the operating temperature in writing, including any pre-cooling. 21 CFR 1.908
- Law On receipt, examine every incoming container and download the data logger before putaway. Wholesalers must examine each container; food receivers must assess for temperature abuse. 21 CFR 205.50
- Law Quarantine the product, physically and in your system. Drugs that may have deteriorated must be quarantined; food cannot be sold until a qualified individual decides it is safe. 21 CFR 205.50
Assess
- Law Record the logger ID, minimum and maximum temperature, time out of range, total duration and chain of custody. Ask the carrier for its temperature records; food carriers must provide them on request. 21 CFR 1.908(e)
- Good practice Calculate mean kinetic temperature only where it applies, and only alongside the manufacturer's stability data, never instead of it. USP <1079> series
- Good practice Contact the manufacturer or marketing authorisation holder. Only they hold the stability data that decides whether the product is still fit. EU GDP Guidelines, chapter 9
Decide and report
- Law Let the quality unit decide disposition: release, reject, return or destroy. Returned drugs with a doubtful storage history must be destroyed or returned unless testing shows they meet standards. 21 CFR 205.50(e)
- Law If product already shipped, trace it by lot through your distribution records and tell the customers who received it. 21 CFR 211.150
- Law Application holders: an NDA holder files a field alert report within 3 working days for significant deterioration of distributed product. A licensed biologics maker reports deviations in distributed product within 45 days. FDA, field alert reports
- Law Food: get a qualified individual's documented decision before any distribution resumes. 21 CFR 1.908(a)(6)
- Good practice Open a corrective action. Find the root cause in the lane, carrier or packaging, fix it and check the fix worked. Keep a written excursion procedure. WHO TRS 961 Annex 9
One-page checklist
- Temperature requirement written into the carrier instructions
- Logger present, started and downloaded on receipt
- Containers examined
- Product quarantined and labelled HOLD
- Minimum, maximum and duration recorded
- Carrier temperature records requested
- Mean kinetic temperature calculated, if it applies
- Manufacturer contacted; written stability assessment received
- Quality unit disposition signed
- Downstream lots traced and customers told
- Field alert or biologic deviation report assessed (3 working days / 45 days)
- Food: qualified individual's decision documented
- Corrective action opened
- Records filed
Who to contact
- Manufacturer or marketing authorisation holder · quality assurance
- FDA district office · field alert reports, Form FDA 3331a · fda.gov
- State board of pharmacy or wholesale licensing body
- Customers who received affected lots
Where Aeroz fits
Aeroz writes every handoff to an append-only EPCIS 2.0 custody log, so when an excursion is found the exact units, lots and receivers affected are already on the record.
Take it with you
The PDF has the full guide and the one-page checklist to print and post by the dock or in the quality office.
A practical guide, not legal advice. Checked 14 Oct 2026; each step links to its source.
A kit covers one incident. A call covers your chain.
In a free 20-minute call we look at your products, partners and handoffs and where a verifiable record would close the gaps.