September 07, 2018
PD-Rx Pharmaceuticals Inc. is recalling more than 6600 bottles of 100-mg doxycycline hyclate USP tablets. According to the September 5, 2018, US Food and Drug Administration (FDA) Enforcement Report, the repackaged lots were recalled by manufacturer West-Ward Pharmaceuticals because samples failed to meet dissolution specifications.
The recall includes the following, which were distributed across the United States:
- 2-count bottles (NDC 55289-866-02) from lots D17D29, L17C73, and F18E73 (Exp. 1/31/19);
- 6-count bottles (NDC 55289-866-06) from lots H17D70, K17F66, and G18F26 (Exp. 1/31/19);
- 7-count bottles (NDC 55289-866-07) from lots C18G26 and F18E36 (Exp. 1/31/19);
- 10-count bottles (NDC 55289-866-10) from lot F18A85 (Exp. 1/31/19);
- 14-count bottles (NDC 55289-866-14) from lots K17B44, K17E29, and L17D93 (Exp. 1/31/19), E17B88 (Exp. 5/31/19), and H17A52 and H17D67 (Exp. 7/31/19);
- 20-count bottles (NDC 55289-866-20) from lots E17B01 and E17E83 (Exp. 5/31/19), F17C99 (Exp. 6/30/19), and G17C08, G17E18, H17B01, H17B66, H17F67, and I17A56 (Exp. 7/31/19);
- 28-count bottles (NDC 55289-866-28) from lots E17E27 (Exp. 1/31/19), and I17A33 and G17D62 ( Exp. 7/31/19);
- 30-count bottles (NDC 55289-866-30) from lots E17B35 and E17D90 (Exp. 5/31/19), F17C13 (Exp. 6/30/19), and G17B25 and H17C58 (Exp. 7/31/19);
- 120-count bottles (NDC 55289-866-98) from lot G17D59 (Exp. 7/31/19);
- 300-count bottles (NDC 55289-866-87) from lots I17A69 and G17D58 (Exp. 7/31/19); and
- 400-count bottles (NDC 55289-866-74) from lot G17D56 (Exp. 7/31/19).
PD-Rx Pharmaceuticals voluntarily initiated the recall August 7, 2018. On August 24, 2018, the FDA designated the recall Class II. Drugs included in Class II recalls may cause temporary or medically reversible adverse health consequences if used. A remote possibility of serious harm also exists.
Doxycycline hyclate is a prescription tetracycline antibiotic used to treat various bacterial infections.
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