NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous U...

FDA Drug Recall #D-0799-2020 — Class II — January 10, 2020

Recall Summary

Recall Number D-0799-2020
Classification Class II — Moderate risk
Date Initiated January 10, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Advanced Accelerator Applications USA, Inc.
Location Millburn, NJ
Product Type Drugs
Quantity 4295 Kits

Product Description

NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.

Reason for Recall

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

Distribution Pattern

Nationwide in the US and Canada

Lot / Code Information

Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.

Other Recalls from Advanced Accelerator Applications USA...

Recall # Classification Product Date
D-0007-2025 Class II Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU... Sep 23, 2024
D-1085-2023 Class III PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 1... Aug 7, 2023
D-0747-2022 Class III NETSPOT (kit for the preparation of Ga 68 dotat... Mar 18, 2022

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.