Why it was recalled
CGMP Deviations
Product description
aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089
Lot numbers, UPCs & expiration codes
Lot # 1407012; Exp. 03/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1053-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 11, 2016
- FDA report date
- Jul 6, 2016
- Quantity
- 577 (212 1 fl oz.. plastic bottles, 167 8 fl oz. plastic bottles, 198 8 fl oz. plastic tubes)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Aloe Source
Original FDA data
Every field from FDA enforcement report D-1053-2016, exactly as published.
Show all FDA fields
- City
- Plano
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 74146
- Address
- 3101 Technology Dr Ste 135
- Code information
- Lot # 1407012; Exp. 03/17
- Postal code
- 75074-3728
- Report date
- Jul 6, 2016
- Product type
- Drugs
- Recall number
- D-1053-2016
- Classification
- Class II
- Recalling firm
- The Aloe Source
- Product quantity
- 577 (212 1 fl oz.. plastic bottles, 167 8 fl oz. plastic bottles, 198 8 fl oz. plastic tubes)
- Termination date
- Mar 31, 2017
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089
- Distribution pattern
- Nationwide
- Recall initiation date
- May 11, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2016