Recalls / Class II
Class IID-1127-2018
Product
Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged By PD-Rx Pharmaceuticals, Oklahoma City, OK 73127.
- Brand name
- Doxycycline
- Generic name
- Doxycycline Hyclate
- Active ingredient
- Doxycycline Hyclate
- Route
- Oral
- NDC
- 55289-866
- FDA application
- ANDA065095
- Affected lot / code info
- Lot #: a) D17D29, L17C73, F18E73, Exp. 1/31/19; b) H17D70, K17F66, G18F26, Exp. 1/31/19; c) C18G26, F18E36, Exp. 1/31/19; d) F18A85, Exp. 1/31/19; e) K17B44, K17E29, L17D93, Exp. 1/31/19; E17B88, Exp. 5/31/19; H17A52, H17D67, Exp. 7/31/19; f) E17B01, E17E83, Exp. 5/31/19; F17C99, Exp. 6/30/19; G17C08, G17E18, H17B01, H17B66, H17F67, I17A56, Exp. 7/31/19; g) E17E27, Exp. 1/31/19, I17A33, G17D62, Exp. 7/31/19; h) E17B35, E17D90, Exp. 5/31/19, F17C13, Exp. 6/30/19, G17B25, H17C58, Exp. 7/31/19; i) G17D59, Exp. 7/31/19; j) I17A69, G17D58, Exp. 7/31/19; k) G17D56, Exp. 7/31/19.
Why it was recalled
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, N/A, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 6,641 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-08-07
- FDA classified
- 2018-08-24
- Posted by FDA
- 2018-09-05
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1127-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.