Balms, creams, a ‘belly rub’ from Broward recalled for ‘Good Manufacturing’ failures
A Dania Beach company that claims its products are “planet friendly” and animal friendly for not using animals in testing wasn’t friendly to the public when it low-keyed a recall of eight products.
According to an FDA enforcement report, Little Moon Essentials didn’t issue a press release about its June 20 recall. A check of the company’s website and social media doesn’t turn up any reference to it, either. The enforcement report says the only “notification of a consignee or the public” was a letter.
As for why Little Moon Essential yanked its products, the enforcement report says only “CGMP deviations,” a reference to Current Good Manufacturing Practice.
“The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product,” the FDA explains. “The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.”
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Here’s what Little Moon, run out of 501 Old Griffin Rd., recalled:
▪ Magical Muscle Oil, 2-ounce glass jars, lot Nos. 325240, 320260, 329011, 324021, 328221, 421110, 422120, 423120, 421220, 426220 and 428220; and 4-ounce jars with lot Nos. 329230, 328140, 320290 and 328011. There were 1,654 glass jars recalled.
▪ Crampy Belly Rub in 4-ounce glass jars, lot No. 224010, and 2-ounce jars with lot Nos. 321260, 322260, 320280, 328080, 325021, 321121, 423010, 427110, 429120, 420220 and 422140. There were 788 glass jars recalled.
▪ Aching Head Rub in half-ounce metal tins with lot Nos. 326070 and 420140; and 1-ounce glass jars with lot Nos. 322030, 321230, 329230, 321240, 329170, 328280, 326090, 322290, 327021, 323121, 327221, 429210, 424130 and 427050. There were 6,312 tins and jars recalled.
▪ Dream Cream in 2-ounce glass jars, lot Nos. 328260, 321221, 425120 and 427230; and 4-ounce glass jars with lot Nos. 327150, 326260, 320270, 321301 and 422020. There were 1,264 jars recalled.
▪ Vital Vapor Balm in half-ounce metal tins with lot No. 324280; 2-ounce glass jars with lot Nos. 328230, 321170, 321290, 326021, 420220 and 422140; and 4-ounce glass jars with lot Nos. 326040 and 328170. There were a total of 1,041 units recalled.
▪ Ass Kisser in half-ounce metal tins, lot No. 327140, and 3-ounce metal tins with lot Nos. 322170, 325040 and 325250. There were 165 metal tins recalled.
▪ Asana Kisser in half-ounce metal tins with lot Nos. 322230 and 424040; and 3-ounce metal tins with lot Nos. 322230, 325070, 324080, 325180, 325280, 328290, 426110, 423210, 426120, 422220, 423130, 428230 and 325040. There were 320 metal tins recalled.
▪ Clear Breeze Plus hand sanitizer in 2-ounce spray bottles and 4-ounce spray bottles, both with lot No. 023170. There were 20 spray bottles recalled.
If you experience any medical problems related to these, first, call a medical professional. Then, notifiy the FDA MedWatch Adverse Event reporting system either online or by calling 888-463-6332 (INFO-FDA).
