NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and...
FDA Drug Recall #D-897-2013 — Class III — June 28, 2013
Recall Summary
| Recall Number | D-897-2013 |
| Classification | Class III — Low risk |
| Date Initiated | June 28, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stayma Consulting Service, LLC. |
| Location | Suwanee, GA |
| Product Type | Drugs |
| Quantity | 1) 4546 bottles and 2) 1349 bottles |
Product Description
NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE
Reason for Recall
Subpotent; Beta carotene (Vitamin A)
Distribution Pattern
Nationwide.
Lot / Code Information
1) Lot 41065, exp 10/14 and 41099, exp 9/14 NDC 44118-902-90 2) Lot 41065A, exp. 9/14 NDC 44118-902-05
Other Recalls from Stayma Consulting Service, LLC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-900-2013 | Class III | Nata Komplete, containing one 30-count bottle o... | Jun 28, 2013 |
| D-899-2013 | Class III | Duet DHA 430 ec, containing one 30-count bottle... | Jun 28, 2013 |
| D-898-2013 | Class III | Duet DHA 430, containing one 30-count bottle of... | Jun 28, 2013 |
| D-895-2013 | Class III | Duet DHA 400, containing one 30-count bottle of... | Jun 28, 2013 |
| D-894-2013 | Class III | Duet DHA Balanced, 1) 30 count tablet blister c... | Jun 28, 2013 |
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.