Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Ap...

FDA Drug Recall #D-0498-2019 — Class III — February 6, 2019

Recall Summary

Recall Number D-0498-2019
Classification Class III — Low risk
Date Initiated February 6, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Advanced Pharma Inc.
Location Houston, TX
Product Type Drugs
Quantity 672 bags

Product Description

Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.

Reason for Recall

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

Distribution Pattern

Nationwide in the USA.

Lot / Code Information

Lots: 12/14/18 1482 70399P, BUD: 02/27/19; 12/14/18 1610 70399P, BUD: 02/27/19

Other Recalls from Advanced Pharma Inc.

Recall # Classification Product Date
D-1251-2019 Class II HYDROmorphone 20 mg/100 mL Injectable Solution,... Apr 26, 2019
D-1023-2019 Class II Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride... Mar 13, 2019
D-1017-2019 Class II fentaNYL 1000 mcg/100 mL Injectable Solution Fe... Mar 13, 2019
D-1026-2019 Class II 2% Lidocaine HCl Injectable Solution, 60 mg/3 m... Mar 13, 2019
D-1033-2019 Class II Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectab... Mar 13, 2019

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced 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.