Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 6...

FDA Drug Recall #D-0807-2018 — Class II — April 24, 2018

Recall Summary

Recall Number D-0807-2018
Classification Class II — Moderate risk
Date Initiated April 24, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Prescript Pharmaceuticals, Inc.
Location Pleasanton, CA
Product Type Drugs
Quantity 24 473-ml bottles

Product Description

Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482

Reason for Recall

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

Distribution Pattern

California.

Lot / Code Information

Lot # 130128, EXP 08/31/20

Other Recalls from Prescript Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0806-2018 Class II Acetaminophen 300 mg with Codeine Phosphate 30 ... Apr 24, 2018
D-0809-2018 Class II Acetaminophen 300 mg with Codeine Phosphate 30 ... Apr 24, 2018
D-0805-2018 Class II Clindamycin 150 mg capsules, USP, 30-count M-Pa... Apr 24, 2018
D-0808-2018 Class II Clindamycin 300 mg capsules, USP, 28-count M-Pa... Apr 24, 2018

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.