Health. Physiological serum: massive recall of several batches
On April 25, the ANSM announced a first recall of two batches of HappyLab brand saline solutions. Traces of cleaning alcohol were identified in some bottles.
According to our colleagues at La Presse de la Manche , a two and a half year old child had to be admitted to the emergency room after nasal washing with one of the incriminated products.
Gaps in the manufacturing processFollowing this event, the Portuguese health authority Infarmed carried out a thorough inspection of GSL production sites.
The results revealed significant deficiencies in good manufacturing practices, including insufficient control and documentation of the 96% ethanol tank cleaning process.
Infarmed has therefore decided to suspend " temporarily and until the correction of the detected irregularities " the manufacture of devices placed on the market by GSL for five brands: Ainsifont, GSL, Happylab, Mediphysio and Stentil.
In France, the ANSM followed suit and, in turn, decided to extend the recall to all batches produced by GSL for all brands distributed in France. The cause: the risk of traces of cleaning alcohol in the saline solution.
Consumers in possession of these products are advised not to use them and to return them to a pharmacy or drugstore, or simply to throw them away.
Remember that physiological serum is a sterile solution of salt water (0.9% sodium chloride) widely used for its cleansing and soothing properties. It is mainly used for:
- rinse eyes if irritation occurs;
- perform nasal washes to decongest the respiratory tract;
- moisturize the nasal mucous membranes, especially in infants etc.
| Trade Name | Lots |
| HAPPYLAB 500 ml | 24136 |
| HAPPYLAB 500 ml | 24137 |
| HAPPYLAB 500 ml | 24140 |
| HAPPYLAB 500 ml | 24141 |
| HAPPYLAB 500 ml | 24168 |
| HAPPYLAB 500 ml | 24169 |
| HAPPYLAB 500 ml | 24170 |
| HAPPYLAB 500 ml | 24171 |
| HAPPYLAB 500 ml | 24172 |
| HAPPYLAB 500 ml | 24175 |
| HAPPYLAB 500 ml | 24179 |
| HAPPYLAB 500 ml | 24178 |
| HAPPYLAB 500 ml | 24182 |
| HAPPYLAB 500 ml | 24183 |
| HAPPYLAB 500 ml | 24185 |
| HAPPYLAB 500 ml | 24186 |
| HAPPYLAB 500 ml | 24193 |
| HAPPYLAB 500 ml | 24196 |
| HAPPYLAB 500 ml | 24213 |
| HAPPYLAB 500 ml | 24214 |
| HAPPYLAB 500 ml | 24218 |
| HAPPYLAB 500 ml | 24219 |
| HAPPYLAB 500 ml | 24220 |
| HAPPYLAB 500 ml | 24221 |
| HAPPYLAB 500 ml | 24245 |
| HAPPYLAB 500 ml | 24247 |
| HAPPYLAB 500 ml | 24248 |
| HAPPYLAB 500 ml | 24249 |
| HAPPYLAB 500 ml | 24252 |
| HAPPYLAB 500 ml | 24253 |
| HAPPYLAB 500 ml | 24254 |
| HAPPYLAB 500 ml | 24256 |
| HAPPYLAB 500 ml | 24261 |
| HAPPYLAB 500 ml | 24288 |
| HAPPYLAB 500 ml | 24289 |
| HAPPYLAB 500 ml | 24291 |
| HAPPYLAB 500 ml | 24294 |
| HAPPYLAB 500 ml | 24295 |
| HAPPYLAB 500 ml | 24296 |
| HAPPYLAB 500 ml | 24297 |
| HAPPYLAB 500 ml | 24298 |
| HAPPYLAB 500 ml | 25002 |
| HAPPYLAB 500 ml | 25015 |
| HAPPYLAB 500 ml | 25029 |
| HAPPYLAB 500 ml | 25030 |
| HAPPYLAB 500 ml | 25031 |
| HAPPYLAB 500 ml | 25034 |
| HAPPYLAB 500 ml | 25042 |
| HAPPYLAB 500 ml | 25044 |
| HAPPYLAB 500 ml | 25048 |
| HAPPYLAB 500 ml | 25049 |
| HAPPYLAB 500 ml | 25050 |
| HAPPYLAB 500 ml | 25052 |
| HAPPYLAB 500 ml | 25056 |
| HAPPYLAB 500 ml | 25057 |
| HAPPYLAB 500 ml | 25058 |
| HAPPYLAB 500 ml | 25059 |
| HAPPYLAB 500 ml | 25080 |
| HAPPYLAB 500 ml | 25086 |
| HAPPYLAB 500 ml | 25105 |
| HAPPYLAB 500 ml | 25016 |
| HAPPYLAB 500 ml | 25107 |
| HAPPYLAB 500 ml | 24142 |
| HAPPYLAB 500 ml | 24143 |
| HAPPYLAB 500 ml | 24144 |
| HAPPYLAB 500 ml | 24147 |
| HAPPYLAB 500 ml | 24168 |
| HAPPYLAB 500 ml | 24254 |
| HAPPYLAB 500 ml | 24256 |
| HAPPYLAB 500 ml | 24259 |
| HAPPYLAB 500 ml | 24260 |
| HAPPYLAB 500 ml | 24261 |
| HAPPYLAB 500 ml | 24263 |
| HAPPYLAB 500 ml | 24266 |
| HAPPYLAB 500 ml | 24287 |
| HAPPYLAB 500 ml | 25034 |
| HAPPYLAB 500 ml | 25043 |
| HAPPYLAB 500 ml | 25045 |
| HAPPYLAB 500 ml | 25055 |
| HAPPYLAB 500 ml | 25056 |
| HAPPYLAB 500 ml | 25079 |
| HAPPYLAB 500 ml | 25080 |
| HAPPYLAB 500 ml | 25085 |
| HAPPYLAB 500 ml | 25097 |
| HAPPYLAB 500 ml | 25098 |
| HAPPYLAB 500 ml | 25100 |
| HAPPYLAB 500 ml | 25101 |
| HAPPYLAB 500 ml | 25104 |
| HAPPYLAB 500 ml | 25105 |
| AINSIFONT 1000 ML | 24317 |
| AINSIFONT 1000 ML | 24318 |
| AINSIFONT 1000 ML | 24319 |
| AINSIFONT 1000 ML | 24322 |
| AINSIFONT 1000 ML | 24337 |
| AINSIFONT 1000 ML | 24334 |
| AINSIFONT 1000 ML | 24338 |
| AINSIFONT 1000 ML | 25016 |
| AINSIFONT 1000 ML | 25017 |
| AINSIFONT 1000 ML | 25020 |
| AINSIFONT 1000 ML | 25021 |
| AINSIFONT 1000 ML | 25035 |
| AINSIFONT 1000 ML | 25036 |
| AINSIFONT 1000 ML | 25037 |
| AINSIFONT 1000 ML | 25059 |
| AINSIFONT 1000 ML | 25064 |
| AINSIFONT 1000 ML | 25065 |
| AINSIFONT 1000 ML | 25066 |
| AINSIFONT 1000 ML | 25069 |
| AINSIFONT 1000 ML | 25070 |
| AINSIFONT 500 ML | 24310 |
| AINSIFONT 500 ML | 24311 |
| AINSIFONT 500 ML | 24312 |
| AINSIFONT 500 ML | 24323 |
| AINSIFONT 500 ML | 24330 |
| AINSIFONT 500 ML | 24331 |
| AINSIFONT 500 ML | 24337 |
| AINSIFONT 500 ML | 24340 |
| AINSIFONT 500 ML | 24343 |
| AINSIFONT 500 ML | 24344 |
| AINSIFONT 500 ML | 25014 |
| AINSIFONT 500 ML | 25021 |
| AINSIFONT 500 ML | 25022 |
| AINSIFONT 500 ML | 25023 |
| AINSIFONT 500 ML | 25024 |
| AINSIFONT 500 ML | 25027 |
| AINSIFONT 500 ML | 25028 |
| AINSIFONT 500 ML | 25034 |
| AINSIFONT 500 ML | 25056 |
| AINSIFONT 500 ML | 25062 |
| AINSIFONT 500 ML | 25066 |
| AINSIFONT 500 ML | 25087 |
| AINSIFONT 500 ML | 25090 |
| AINSIFONT 500 ML | 25091 |
| AINSIFONT 500 ML | 25092 |
| GSL 1000 ML | 24267 |
| GSL 1000 ML | 24268 |
| GSL 1000 ML | 24269 |
| GSL 1000 ML | 24270 |
| GSL 1000 ML | 24277 |
| GSL 1000 ML | 24280 |
| GSL 500 ML | 24273 |
| GSL 500 ML | 24274 |
| GSL 500 ML | 24275 |
| GSL 500 ML | 24276 |
| GSL 500 ML | 24281 |
| GSL 500 ML | 24282 |
| GSL 500 ML | 24283 |
| GSL 500 ML | 24284 |
| GSL 500 ML | 24289 |
| GSL 500 ML | 24301 |
| GSL 500 ML | 24303 |
| GSL 500 ML | 24304 |
| GSL 500 ML | 24308 |
| GSL 500 ML | 24309 |
| GSL 500 ML | 24312 |
| GSL 500 ML | 25014 |
| MEDIPHYSIO 500 ML | 24323 |
| MEDIPHYSIO 500 ML | 24324 |
| MEDIPHYSIO 500 ML | 24325 |
| MEDIPHYSIO 500 ML | 24329 |
| MEDIPHYSIO 500 ML | 24330 |
| MEDIPHYSIO 500 ML | 24331 |
| MEDIPHYSIO 500 ML | 24332 |
| MEDIPHYSIO 500 ML | 24333 |
| MEDIPHYSIO 500 ML | 24336 |
| MEDIPHYSIO 500 ML | 24337 |
| MEDIPHYSIO 500 ML | 24346 |
| MEDIPHYSIO 500 ML | 24347 |
| MEDIPHYSIO 500 ML | 24350 |
| MEDIPHYSIO 500 ML | 24351 |
| MEDIPHYSIO 500 ML | 25003 |
| MEDIPHYSIO 500 ML | 25006 |
| MEDIPHYSIO 500 ML | 25007 |
| MEDIPHYSIO 500 ML | 25008 |
| MEDIPHYSIO 500 ML | 25009 |
| MEDIPHYSIO 500 ML | 25010 |
| STENTIL 1000 ML | 25093 |
| STENTIL 1000 ML | 25094 |
| STENTIL 1000 ML | 25097 |
| STENTIL 1000 ML | 25098 |
| STENTIL 1000 ML | 25099 |
| STENTIL 500 ML | 25070 |
| STENTIL 500 ML | 25073 |
| STENTIL 500 ML | 25076 |
| STENTIL 500 ML | 25077 |
| STENTIL 500 ML | 25078 |
| STENTIL 500 ML | 25079 |
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