FDA Drug recall D-1588-2012
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML
- FDA Drug
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 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-1588-2012 |
| 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
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML; NANDROLONE DECANOATE 100MG/ML INJECTABLE 5 ML; NANDROLONE DECANOATE 300MG/ML INJECTABLE 10 ML 30 ML (6 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: C0371167 C0371185 C0371187 C0371193 C0381331 C0381336 C0381348 C0381353 C0381360 C0381364 C0381366…Rx #'s: C0371167 C0371185 C0371187 C0371193 C0381331 C0381336 C0381348 C0381353 C0381360 C0381364 C0381366 C0381371 C0384632 C0384634 C0384637 C0389199 C0389200 C0389201 C0389205 C0389216 C0389219 C0389223 C0389224 C0392398 C0392399 C0392401 C0392405 C0392407 C0392409 C0392410 C0392411 C0392412 C0392414 C0392418 C0392419 C0392421 C0392426 C0392429 C0392433 C0392434 C0392435 C0392436 C0392438 C0392441 C0394169 C0394170 C0394171 C0394172 C0394173 C0394174 C0394175 C0394176 C0394177 C0394178 C0394179 C0394180 C0396357 C0396362 C0396365 C0396370 C0396374 C0396377 C0396388 C0396397 C0396398 C0397477 C0397478 C0397479 C0397481 C0397482 C0397484 C0397486 C0397487 C0397488 C0397489 C0397491 C0397492 C0397493 C0397494 C0397495 C0397496 C0397497 C0397498 C0397500 C0397501 C0397502 C0400024 C0400033 C0400034 C0400035 C0400036 C0400037 C0400038 C0400039 C0400040 C0400041 C040 |
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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-1588-2012%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.