FDA Drug recall D-1573-2012
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
- FDA Drug
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of 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 by Franck S Lab D B A Franck S Compounding Lab, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1573-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-21 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Franck S Lab D B A Franck S Compounding Lab |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Rx #'s: 0391301 0391927 0397282 0399470 0391327 0392711 0394996 0401004 0395010 0388696…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1573-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.