D-0948-2017 Class II Terminated
FDA drug recall D-0948-2017 was initiated by Phillips Co. on June 8, 2017 and is designated Class II. Reason for recall: GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. The recall status is terminated (terminated July 20, 2020). Affected quantity: 200-300 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 12, 2017
- Initiation Date
- June 8, 2017
- Termination Date
- July 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200-300 bottles
Product Description
TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11
Reason for Recall
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Distribution Pattern
Nationwide and United Kingdom
Code Information
All lots remaining within expiry.