METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 M...
FDA Drug Recall #D-1573-2012 — Class II — May 21, 2012
Recall Summary
| Recall Number | D-1573-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 21, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| Location | Ocala, FL |
| Product Type | Drugs |
| Quantity | 208 units |
Product Description
METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS 4 ML 40 ML 5 ML 6 ML 60 ML 80 ML 90 ML; METHYLCOBALAMIN ( DR HALL KIT) 1,000MCG/ML INJECTABLE 1 KIT 1 ML 10 ML 30 ML; METHYLCOBALAMIN ( DR HALL KIT) PRESERVATIVE FREE 1,000MCG/ML INJECTABLE 1 KIT; METHYLCOBALAMIN (PRESERV FREE) 1,000MCG/ML INJECTABLE 4 ML 8 ML; METHYLCOBALAMIN (PRESERV FREE) 25,000MCG/ML INJECTABLE 1.5 ML 3 ML 3.5 ML 60 ML; METHYLCOBALAMIN (PRESERVATIVE FREE) 25MG/ML INJECTABLE 30 ML 4 ML 8 ML; METHYLCOBALAMIN 5,000MCG/ML INJECTABLE 6 ML (31 DIFFERENT PRODUCTS)
Reason for Recall
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Distribution Pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Lot / Code Information
Rx #'s: 0391301 0391927 0397282 0399470 0391327 0392711 0394996 0401004 0395010 0388696 0389279 0401772 0402650 0404045 0404779 0406029 0408374 0403432 0392999 0395958 0396932 0398177 0405143 0405968 0407753 0365101 0365105 0365106 0365108 0371252 0371257 0371265 0371268 0371270 0382419 0391063 0391522 0393199 0403490 0406625 0406627 0406630 0409573 0409579 0409599 0403432 0387860 0388243 0389493 0390022 0390530 0391010 0391294 0391645 0392576 0392665 0392688 0392894 0393040 0393092 0393216 0393335 0393561 0393731 0395678 0396033 0397292 0398299 0398311 0399018 0400098 0400351 0400429 0400575 0400578 0400982 0401079 0401385 0401646 0401948 0402176 0402516 0402557 0402580 0402987 0403982 0405357 0405430 0405445 0407384 0407808 0407965 0408244 0408382 0408419 0408726 0408792 0409348 0381200 0361853 0392328 0394367 0399209 0390487 0391522 0397635 0381200 0380708 0352927 0361537 0367181 0371957 0373468 0375263 0376692 0378305 0381683 0382865 0384081 0385565 0387059 0387814 0388443 0388942 0388944 0389430 0391105 0397310 0400625 0402660 0403566 0407971 0407993 0388536 0388536 0368410 0388443 0396037 0397310 0400776 0404858 0405790 0404952 0369001 0367492 0400900 0371731 0371731 0371731 0400549 0406613 0392439 0392439 0401628 0392136
Other Recalls from Franck's Lab Inc., d.b.a. Franck's Co...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1513-2012 | Class II | ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PR... | May 25, 2012 |
| D-1452-2012 | Class II | ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, ... | May 25, 2012 |
| D-1514-2012 | Class II | EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJ... | May 25, 2012 |
| D-1451-2012 | Class II | AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16"... | May 25, 2012 |
| D-1492-2012 | Class II | CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%... | May 25, 2012 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
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.