Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM ...

FDA Drug Recall #D-1522-2014 — Class II — June 25, 2014

Recall Summary

Recall Number D-1522-2014
Classification Class II — Moderate risk
Date Initiated June 25, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medical Supply Liquidators Llc
Location Clive, IA
Product Type Drugs
Quantity N/A

Product Description

Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us

Reason for Recall

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Distribution Pattern

Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.

Lot / Code Information

All lot numbers and exp dates

Other Recalls from Medical Supply Liquidators Llc

Recall # Classification Product Date
D-1527-2014 Class II Vitamin B12 Cyanocobalamin with MIC Injection U... Jun 25, 2014
D-1528-2014 Class II B Complex for Injection USP with Methylcobalami... Jun 25, 2014
D-1525-2014 Class II MIC Injection USP, Sterile, 10 ml vial and 30 m... Jun 25, 2014
D-1519-2014 Class II Vitamin B12 Methylcobalamin with MIC Injection ... Jun 25, 2014
D-1520-1014 Class II Vitamin B12 Methylcobalamin Injection USP 1000 ... Jun 25, 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.