Why it was recalled
Failed dissolution specifications
Product description
Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Lot numbers, UPCs & expiration codes
Lots: a) L18B72, Exp 12/31/2020; b)I18B83, Exp 06/30/2020 ; c) H18B11, Exp 06/30/2020; I18A53, Exp 06/30/2020; J18F97, Exp 10/31/2020; K18A33, Exp 11/30/2020; K18D17, Exp 11/30/2020; L18A11, Exp 12/31/2020; L18A29, Exp 12/31/2020; L18D81, Exp 12/31/2020; d) H18F60, Exp 06/30/2020; I18C26, Exp 06/30/2020; I18D61, Exp. 06/30/2020; J18B80, Exp 10/31/2020; K18C97 Exp 11/30/2020; L18B30, Exp. 12/31/2020; L18D25, Exp 12/31/2020; L18E50 Exp 12/31/2020; e) I18D07, Exp. 06/30/2020; J1E02, Exp 10/31/2020; J18E62 Exp 10/31/2020; K18E98 Exp. 11/30/2020; L18C54, Exp 12/31/2020; f) H18E18 Exp. 06/30/2020, I18F94 Exp. 09/30/2020, J18E42, Exp. 10/31/2020, L18B56 Exp. 12/31/2020; g) J18C84 Exp. 10/31/2020, A19B70 Exp. 01/31/2021; h) K18E92 Exp. 11/30/2020; i) I18E80 Exp. 06/30/2020, K18A19 Exp. 11/30/2020; j) F18E11 Exp. 06/30/2020, G18E66 Exp. 06/30/2020, H18E72 Exp. 06/30/2020, I18E75 Exp. 09/30/2020, I18E95 Exp. 09/30/2020, I18F64 Exp. 09/30/2020; k) A19D44 Exp. 08/31/2020, H18E76 Exp. 06/30/2020, I18F21 Exp. 09/30/2020, L18B91 Exp. 12/31/2020
Where it was sold
USA 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-1276-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2020
- FDA report date
- Jun 3, 2020
- Quantity
- 14,030 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1276-2020, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 85724
- Address
- 727 N Ann Arbor Ave
- Code information
- Lots: a) L18B72, Exp 12/31/2020; b)I18B83, Exp 06/30/2020 ; c) H18B11, Exp 06/30/2020; I18A53, Exp 06/30/2020; J18F97, Exp 10/31/2020; K18A33, Exp 11/30/2020; K18D17, Exp 11/30/2020; L18A11, Exp 12/31/2020; L18A29, Exp 12/31/2020; L18D81, Exp 12/31/2020; d) H18F60, Exp 06/30/2020; I18C26, Exp 06/30/2020; I18D61, Exp. 06/30/2020; J18B80, Exp 10/31/2020; K18C97 Exp 11/30/2020; L18B30, Exp. 12/31/2020; L18D25, Exp 12/31/2020; L18E50 Exp 12/31/2020; e) I18D07, Exp. 06/30/2020; J1E02, Exp 10/31/2020; J18E62 Exp 10/31/2020; K18E98 Exp. 11/30/2020; L18C54, Exp 12/31/2020; f) H18E18 Exp. 06/30/2020, I18F94 Exp. 09/30/2020, J18E42, Exp. 10/31/2020, L18B56 Exp. 12/31/2020; g) J18C84 Exp. 10/31/2020, A19B70 Exp. 01/31/2021; h) K18E92 Exp. 11/30/2020; i) I18E80 Exp. 06/30/2020, K18A19 Exp. 11/30/2020; j) F18E11 Exp. 06/30/2020, G18E66 Exp. 06/30/2020, H18E72 Exp. 06/30/2020, I18E75 Exp. 09/30/2020, I18E95 Exp. 09/30/2020, I18F64 Exp. 09/30/2020; k) A19D44 Exp. 08/31/2020, H18E76 Exp. 06/30/2020, I18F21 Exp. 09/30/2020, L18B91 Exp. 12/31/2020
- Postal code
- 73127-5822
- Report date
- Jun 3, 2020
- Product type
- Drugs
- Recall number
- D-1276-2020
- Classification
- Class II
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Product quantity
- 14,030 bottles
- Termination date
- Nov 8, 2021
- Reason for recall
- Failed dissolution specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 15, 2020
- Initial firm notification
- Letter
- Center classification date
- May 26, 2020