Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: 17E039, Exp. 05/2019; 17K016, Exp. 10/2019; 18E021, Exp. 05/2020; 18G008, Exp. 07/2020.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Torrent Pharma Inc
- Reason for Recall:
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.
Product Codes/Lot Numbers:
Lot #s: 17E039, Exp. 05/2019; 17K016, Exp. 10/2019; 18E021, Exp. 05/2020; 18G008, Exp. 07/2020.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1359-2019
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