Tychasis Coats Aloe Liniment recalled for failed stability specs
Certain lots of Tychasis Coats Aloe Liniment (methyl salicylate 10%) in 0.5 oz, 8 oz and 33 oz bottles are recalled. Stability testing found viscosity and appearance results that did not meet the established specifications. No injuries have been reported, and the product was distributed only in Texas.
From the FDA notice · Read the official notice ↗
What to do
- Stop using bottles from the lots listed below and set them aside.
- 8 oz bottles (NDC 70211-704-08): lot 0001882605 or 0001916439, expiration Jul-31-2027.
- 33 oz bottles (NDC 70211-704-33): lot 0001882606, expiration Jul-31-2027.
- 0.5 oz professional sample (no NDC): lot 0001882607, expiration Jul-31-2027.
- The notice doesn't say how to get a refund or replacement; contact BioMed Laboratories, LLC, or where you bought it.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Tychasis Coats Aloe Liniment (Methyl salicylate 10%), packaged a) 0.5 oz, b) 8 oz (NDC 70211-704-08) c) 33oz (NDC 70211-704-33) bottles, Manufactured for: Tychasis Corporation, Dallas, TX 75227. There is no NDC for the 0.5 oz given that it is a sample size used as a professional sample.
- Sold in
- TX only
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 11,130 bottles
- Illnesses reported
- None reported
- Manufactured in
- 8181 Eastpoint Dr Ste 100-500, Dallas, Texas, United States
- Classification
- Class II
- Recall number
- D-0161-2027
In the FDA's words
- Description
- Tychasis Coats Aloe Liniment (Methyl salicylate 10%), packaged a) 0.5 oz, b) 8 oz (NDC 70211-704-08) c) 33oz (NDC 70211-704-33) bottles, Manufactured for: Tychasis Corporation, Dallas, TX 75227. There is no NDC for the 0.5 oz given that it is a sample size used as a professional sample. Failed Stability Specifications: OOS stability results included viscosity and appearance results that did not align with the established specifications. Lot #: a)0.5 oz 0001882607, Exp. Date Jul-31-2027; b) 0001882605, 0001916439 Exp. Date Jul-31-2027; c) Lot #: 0001882606, Exp. Date Jul-31-2027 Distribution: TX only Affected quantity: 11,130 bottles
- Hazard
- Failed Stability Specifications: OOS stability results included viscosity and appearance results that did not align with the established specifications.
3 products in this recall
Tychasis Coats aloe products recalled for failed stability tests
BioMed Laboratories is recalling three Tychasis Coats products: aloe lotion (allantoin 0.5%), aloe creme (allantoin 0.5%) and aloe liniment (methyl salicylate 10%), in several bottle and jar sizes. The FDA reports that stability test results for viscosity and appearance did not align with the established specifications. The products were distributed in Texas only, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Tychasis Coats Aloe Lotion (Allantoin 0.5%) packaged in a)0.5 oz, b)8 oz (NDC 70211-704-08), and c)33 oz (NDC 70211-704-33) bottles, Manufactured for: Tychas…D-0159-2027 · 13,128 bottles
- Tychasis Coats Aloe Creme (Allantoin 0.5%), packaged in a) 4oz (NDC 70211-703-04), and b)16 oz (NDC 70211-703-16) jars, Manufactured for: Tychasis Corporatio…D-0160-2027 · 12,028 jars
- Tychasis Coats Aloe Liniment (Methyl salicylate 10%), packaged a) 0.5 oz, b) 8 oz (NDC 70211-704-08) c) 33oz (NDC 70211-704-33) bottles, Manufactured for: Ty… (this page)D-0161-2027 · 11,130 bottles