Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, M...

FDA Drug Recall #D-764-2014 — Class I — August 29, 2013

Recall Summary

Recall Number D-764-2014
Classification Class I — Serious risk
Date Initiated August 29, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cubist Pharmaceuticals, Inc.
Location Lexington, MA
Product Type Drugs
Quantity 179,870 vials

Product Description

Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA

Reason for Recall

Presence of Particulate Matter; Glass particulates observed in vials

Distribution Pattern

Nationwide

Lot / Code Information

Lot Numbers: Lot 950453F, Exp. 12/06/2013 Lot 090203F, Exp. 09/07/2014 Lot 201703F, Exp. 08/31/2015 Lot 201653F, Exp. 09/01/2015

Other Recalls from Cubist Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0229-2015 Class I CUBICIN (daptomycin for injection) 500 mg, For ... Aug 8, 2014
D-0001-2015 Class I CUBICIN (daptomycin for injection), 500 mg sing... Aug 1, 2014
D-1382-2014 Class I CUBICIN (daptomycin for injection), 500 mg sing... Apr 17, 2014

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.