Reported Aug 22, 2012 · Terminated
MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE,…
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Franck's Lab Inc., d.b.a. Franck's Compounding Lab · 1210 SW 33rd Avenue · Ocala, FL · 34474-5138
Is this the product you have?
20 of 20 products
| # | Product as published |
|---|---|
| 1 | MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML |
| 2 | MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML |
| 3 | MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML |
| 4 | MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML |
| 5 | MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 20MG/ML INTRATHECAL 18 ML 40 ML |
| 6 | MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 25MG/ML INTRATHECAL 20 ML 40 ML |
| 7 | MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 38MG/ML INTRATHECAL 50 ML |
| 8 | MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 5MG/ML INTRATHECAL 40 ML |
| 9 | MORPHINE SULFATE, P.F. 10MG/ML INTRATHECAL 40 ML |
| 10 | MORPHINE SULFATE, P.F. 11.5MG/ML INTRATHECAL 35 ML |
| 11 | MORPHINE SULFATE, P.F. 1MG/ML INJECTABLE 250 ML |
| 12 | MORPHINE SULFATE, P.F. 25MG/ML INTRATHECAL 30 ML |
| 13 | MORPHINE SULFATE, P.F. 30MG/ML INTRATHECAL 18 ML |
| 14 | MORPHINE SULFATE, P.F. 33MG/ML INTRATHECAL 30 ML |
| 15 | MORPHINE SULFATE, P.F. 35MG/ML INTRATHECAL 35 ML |
| 16 | MORPHINE SULFATE, P.F. 40MG/ML INTRATHECAL 18 ML 20 ML 35 ML |
| 17 | MORPHINE SULFATE, P.F. 42MG/ML INTRATHECAL 35 ML |
| 18 | MORPHINE SULFATE, P.F. 50MG/ML INTRATHECAL 18 ML 40 ML |
| 19 | MORPHINE SULFATE, P.F. 5MG/ML INTRATHECAL 40 ML |
| 20 | MORPHINE SULFATE/BACLOFEN P.F. 25MG/1500MCG/ML INTRATHECAL 18 ML (28 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:N0396046
91 of 91 codes
N0397450N0404861N0404320N0389241N0398238N0408869N0396836N0390297N0393345N0393647N0395395N0397377N0400800N0403100N0405536N0408890N0390024N0391848N0398239N0403727N0386864N0388540N0391192N0391588N0391831N0391832N0395396N0396449N0403824N0403830N0405260N0405432N0406253N0407952N0408884N0393648N0408194N0394358N0397366N0397367N0398708N0398710N0399636N0400170N0403098N0405257N0391608N0401173N0403253N0405115N0406436N0390298N0395170N0407252N0407520N0392176N0399300N0406567N0407428N0387601
- Rx #'s:N0396046
- Amount recalled
- 92 units
This recall covers 198 products
The agency filed one notice per product. You are reading one of them; the other 197 are below.
185 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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